Biological Engineering Career Careers in the United States

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Biological Technician

Cardno ENTRIX is an environmental and natural resource management consultancy providing a broad suite of services in Water Resources Management, Natural Resources Management, Permitting & Compliance, and Liability Management. Clients turn to Cardno ENTRIX for help navigating complex environmental, natural resource, and business challenges because of our creative problem-solving and the successful track record of our multidisciplinary team. Cardno ENTRIX is seeking a temporary Biological Technician in our Las Vegas, NV office. Responsibilities include, but are not limited to: > Biological monitoring, desert tortoise radio tracking...

Sr. Mechanical Engineer

SR. MECHANICAL ENGINEER ? PRODUCT DEVELOPMENT Here at HighRes Biosolutions welove automation. We design and build innovativerobotic systems and laboratory devices used by pharmaceutical and biotechcompanies and academic research laboratories. Our work helps scientistsaccelerate drug discovery, high throughput genotyping, siRNA screening, next-generationsequencing sample prep, biorepository science and molecular diagnostics withhighly flexible, expandable and modular integrated systems, bench-top devicesand consumables that are easily configured (and reconfigured) to createresearch environments conducive to achieving breakthrough results. As a Sr. Mechanical Engineer here, you'll have a hands-on approachto product design and development , with a focus on building medical devices or related instruments forbiological research. Work withmulti-axis devices is critical. In this job, your job responsibilities will include: ? Complete product development life cycle implementation. ? Developing specs and prototyping new concepts. ? Working closely with electrical engineers, firmware development andmechanical engineers. ? Working closely with the testing team to ensure new products meetspecifications. ? Developing and managing timelines and budgets for product development. You'll be working with motioncontrol, servo motors, linear motors, linear actuators, encoders andpneumatics, so any experience in these areas is a plus....

Lab Technician/ Clinical Research Assistant

Lab Technician/ Clinical Research Assistant, Roswell, GA Conduct research in preclinical labs handling rodents and other small animals to apply prototype devices and administer transdermal pharmaceutical doses Independently test efficacy of prototype devices in preclinical and skin models, including performing examinations, tissue isolation and cryostat sectioning, staining, microscopy, optical coherence tomography (OCT), ELISA-based assays and other laboratory techniques. Analyze data, interpret results, prepare reports, and maintain accurate records with minimum supervision Design protocols and perform experiments in collaboration with technical team Responsible with others for the biological and chemical safety of the lab B.S. in Biological Sciences, Chemistry, Pharmaceutical Science or a related scientific discipline with 5+ years experience or M.S. or Ph.D. in biological science with 3 + years experience Excellent record-keeping, careful attention to detail, and good time management skills to successfully manage multiple priorities Strong hands-on working knowledge of in vivo and ex vivo skin models with rodent and small animals Ability to work independently and collaboratively with a multi-disciplined group in a goal- and team- oriented setting is required Positive interpersonal and communication skills, both written and oral, including proficiency with MS Office software Experience with transdermal drug delivery and GLP-regulated research environments is preferred Knowledge of statistical methods and design of experiments (DOE) is preferred...

Microbiology Engineer II

Whether you're just beginning your career or taking your next step toward greater achievements, Smiths Medical offers the global resources, impressive growth and commitment to innovation you need to realize your ambition. JOB PURPOSE: Oversees laboratory microbiological testing and gives day to day work activity direction to microbiology laboratory personnel and provides input to management for performance related issues of employees and does have some input in employee hiring or termination responsibilities. Perform product testing; develop department procedures for use of the equipment. Perform and document microbiological testing for release of incoming components and finished product to support Quality Assurance/Quality Control and manufacturing operations. Monitor particulate and other biological substance levels in controlled environmental room areas. Develop and draft validation protocols and reports, project manages validation activities under the direction and review of the Regional Microbiology Manager. For all testing determine the source of errors and perform troubleshooting on the tests; interpret the significance of results, including trend analysis to provide to management. Provides support on sterilization and biological safety evaluations for current devices and NPI projects in accordance with applicable international guidance documents and under the direction of the Regional Microbiology Manager. Part of a global microbiology team and can be deployed regionally to meet the business needs and supports other microbiology labs or sites as dictated by business needs and under the direction of the Regional Microbiology Manager. Gives guidance on microbiology and sterilization to site where no dedicated Microbiology personnel. Represents Smiths Medical as the site Microbiology representative during regulatory and customer site inspections; and as Legal Manufacturer Microbiology representative for the Manufacturing site....

Senior Scientist / Engineer

Our client, a Healthcare / Medical Device company, is seeking a Senior Scientist / Engineer . The Senior Scientist/Engineer position, Product Development will be working as part of a multi-disciplinary team and be responsible for the development of new consumables in the areas of microfabrication, microfluidics, cell isolation and analysis during feasibility and development. He/She will also be involved in interfacing between the instrument, software and assays in order to refine system requirements and develop the strategy for Integration, System Verification and Validation. Responsibilities: The Senior Scientist / Engineer will be independently responsible for the conception, design, implementation and interpretation of scientific research projects pertaining to the fabrication, process development and testing of microstructure based devices for biological analysis The Senior Scientist / Engineer will be required to conduct experiments on early consumables and prototype/breadboard fixtures in an effort to refine requirements and identify areas of risk and mitigations for those identified areas Additionally, the individual may be required to assist in similar activities for other subsystem areas depending on the nature and complexity of the feasibility and integration activities The Senior Scientist / Engineer will develop concepts, strategy, test plans/protocols and reports for feasibility and integration activities to be compliant with regulatory requirements, and company's procedures He/she will be providing direction to other team members who will be responsible for executing test designs along with the candidate, and performing the data analysis/evaluation to draw conclusions and write reports associated with the activities The Senior Scientist / Engineer will be responsible for effectively interacting with people representing a broad array of technical specialties to achieve success The Senior Scientist / Engineer will be responsible for thinking broadly, unconventionally and being open to new ideas from others...

Sr. Engineer Specialist

The Senior Scientist/Engineer position, Product Development will be working as part of a multi-disciplinary team and be responsible for the development of new consumables in the areas of microfabrication, microfluidics, cell isolation and analysis during feasibility and development. He/She will also be involved in interfacing between the instrument, software and assays in order to refine system requirements and develop the strategy for Integration, System Verification and Validation. The candidate will be independently responsible for the conception, design, implementation and interpretation of scientific research projects pertaining to the fabrication, process development and testing of microstructure based devices for biological analysis. The candidate will be required to conduct experiments on early consumables and prototype/breadboard fixtures in an effort to refine requirements and identify areas of risk and mitigations for those identified areas. Additionally, the individual may be required to assist in similar activities for other subsystem areas depending on the nature and complexity of the feasibility and integration activities. The successful candidate will develop concepts, strategy, test plans/protocols and reports for feasibility and integration activities to be compliant with regulatory requirements, and Client procedures. He/she will be providing direction to other team members who will be responsible for executing test designs along with the candidate, and performing the data analysis/evaluation to draw conclusions and write reports associated with the activities. This person will be responsible for effectively interacting with people representing a broad array of technical specialties to achieve success. He/She will be responsible for thinking broadly, unconventionally and being open to new ideas from others....

Validation Scientist/ Engineer

Job is located in Bradley, IL. Validation Scientist/ Engineer I Position Purpose: Designs, schedules, and executes scientifically sound qualification/validation experiments which demonstrate that manufacturing Equipment, Facilities, Utilities, Systems, and Processes are in compliance with regulatory requirements, product license restrictions, and industry guidance. Prepares detailed concise reports on completed studies that summarize test results and their conformance to the protocol acceptance criteria. Main Responsibilities and Accountabilities: 1 Responsible for achieving validation study objectives/schedules while working across multiple departments. Maintains close contact with appropriate functional groups (i.e. Manufacturing, Engineering, and QC Labs, etc.) to assure effective communication in regards to the needs and status of assigned validation studies 2 Prepares scientifically sound validation protocols that incorporate the defined specifications into acceptance criteria and assessment procedures. 3 Schedules and communicates validation study execution/testing with affected departments and personnel. 4 Collects, interprets, evaluates and communicates validation test data for conformance to validation acceptance criteria and/or to investigate and determine root cause for validation study discrepancies. 5 Prepares detailed, concise reports on completed studies that summarize the test results and their conformance to defined acceptance criteria 6 Researches governmental regulatory requirements and industry guidance on assigned projects to ensure that each study subject is challenged to meet, at least, the minimal required specifications. 7 Assists the department in developing programs and SOPs to meet current industry standards, site Quality, and external Regulatory requirements. 8 Provides technical support/training to Validation Technicians in areas of competency. Provides technical support other functional groups (i.e. Manufacturing, Engineering, and QC Labs, etc.) as needed. 9 Supports the facility in internal and external inspections. 10 Other tasks as required by Departmental Management. Education BS in Engineering, Physical or Biological Science preferred and at least one year pharmaceutical experience. Experience 0-3 years of Validation experience....

Validation Scientist/ Engineer

Validation Scientist/ Engineer I Position Purpose: Designs, schedules, and executes scientifically sound qualification/validation experiments which demonstrate that manufacturing Equipment, Facilities, Utilities, Systems, and Processes are in compliance with regulatory requirements, product license restrictions, and industry guidance. Prepares detailed concise reports on completed studies that summarize test results and their conformance to the protocol acceptance criteria. Main Responsibilities and Accountabilities: 1 Responsible for achieving validation study objectives/schedules while working across multiple departments. Maintains close contact with appropriate functional groups (i.e. Manufacturing, Engineering, and QC Labs, etc.) to assure effective communication in regards to the needs and status of assigned validation studies 2 Prepares scientifically sound validation protocols that incorporate the defined specifications into acceptance criteria and assessment procedures. 3 Schedules and communicates validation study execution/testing with affected departments and personnel. 4 Collects, interprets, evaluates and communicates validation test data for conformance to validation acceptance criteria and/or to investigate and determine root cause for validation study discrepancies. 5 Prepares detailed, concise reports on completed studies that summarize the test results and their conformance to defined acceptance criteria 6 Researches governmental regulatory requirements and industry guidance on assigned projects to ensure that each study subject is challenged to meet, at least, the minimal required specifications. 7 Assists the department in developing programs and SOPs to meet current industry standards, site Quality, and external Regulatory requirements. 8 Provides technical support/training to Validation Technicians in areas of competency. Provides technical support other functional groups (i.e. Manufacturing, Engineering, and QC Labs, etc.) as needed. 9 Supports the facility in internal and external inspections. 10 Other tasks as required by Departmental Management. Education BS in Engineering, Physical or Biological Science preferred and at least one year pharmaceutical experience. Experience 0-3 years of Validation experience....

Software Engineering

Company Overview As the world?s premier measurement company, Agilent works in close collaboration with engineers, scientists, and researchers around the globe to meet the communications, electronics, life sciences, and chemical analysis challenges of today and tomorrow. The company operates two primary businesses -- electronic and bio-analytical measurement -- supported by Agilent Laboratories, its central research group. Agilent is committed to providing innovative measurement solutions that enable our customers and partners-- the leaders in their felds -- to deliver the products and services that make a measurable difference in the lives of people everywhere. Learn More about Agilent Visit Our Company Website Join the fast-paced, high-performance Genomics R&D team in developing novel and profitable product offerings that help advance human health. You?ll discover what we really are ?inventors, scientists, engineers and visionaries working together to deliver the products and services that enable our customers to answer significant biological questions. We are seeking a highly motivated individual to join our team of informatics and software experts. As part of this team, you will contribute to the analysis of genomics data and design of novel software. As a member of the new Agilent business--Diagnostics and Genomics Group, you will play a key role in the success of our business through the development and implementation of novel genomics and molecular biology solutions. Responsibilities ?--------------- ?Analysis of genomics data and perform statistics to answer key questions for clinical research. ?Hands-on development of internal pipeline to analyze and perform statistics on genomics data. ?Hands-on development of customer facing software applications for analyzing microarray, next generation sequencing or other genomic data. ?Maintain and document current code base ?Extend and implement new algorithms, quality control metrics, statistics on output results and validate output ?Coordinate and facilitate communications with other departments and/or commercial vendors to investigate and resolve software matters of significance and to ensure proper functioning of systems. ?Design architecture to efficiently handle large datasets...

Lead Biostatistics Engineer, Lead Programmer Analyst

Lead Programmer Analyst, Multiple Openings. Bear, DE and unanticipated client sites throughout the United States. Analyze user requirements, programs, procedures, and problems to automate and improve existing systems and review these system capabilities, workflows, and scheduling limitations. Test, maintain, and monitor computer programs and systems, including coordinating the installation of computer programs and systems. Work independently, providing project status reports and formal presentations as required. Requirements: MS or equiv. in CS, CIS, Computer Applications, Engg., IT, Math., Electronics, Business, Manag., Techn. or related with no experience. In lieu of Master?s degree, employer is willing to accept the U.S. equiv. to a Bachelor?s Degree with five years of prior progressive professional experience in position offered or related position. Position requires extended travel and/or relocation. Mail resumes to: Mican Technologies, Inc., Job # LPA, 2500 Wrangle Hill Road, Suite 224, Bear, DE 19701. Lead Biostatistics Engineer . Bear, DE and unanticipated client sites throughout the United States. Lead application development, database development, and data management for Clinical Trials and Bio statistics using QlikView. Database design, administration, query, forms design, and reporting knowledge of regulations relating to clinical data management, and knowledge of a clinical data management systems; design and development of analysis, testing and comparing methodologies using QlikView for results of clinical trials and therapies performed by the Pharmaceutical Industries; development and maintenance of software pipelines and visualization tools for genomic annotation and analysis, application of biological knowledge to data analysis and report development. Requirements: MS or equiv. in Science, Biology, Bio Technology or related. No experience. Position requires extended travel and/or relocation. Mail resumes to: Mican Technologies, Inc., Job # LBE, 2500 Wrangle Hill Road, Suite 224, Bear, DE 19701....

Account Manager, Academia

Carl Zeiss Microscopy, LLC, located in Thornwood, New York, provides industry-leading and innovative microscopy and imaging solutions for bioscience, materials and industrial research, educational and routine microscopy. Carl Zeiss Microscopy is a provider of key enabling technologies in both high tech industries and life sciences research. We are uniquely positioned to play a major role in helping our customers find the answers to the most pressing challenges of biological and material science. Account Manager, Academia - Seattle, WA Primary Duties & Responsibilities: Selling and support of ZEISS instrumentation in the Bioscience and Materials market. Perform presentations of ZEISS products, independently and in a team setting. Provide technical training as required. Responsible for proper management of demo equipment, including proper documentation of loaned equipment and proper completion of annual cycle counts. Provide feedback to the Product Manager based on product trend observations in the market. Education & Experience: Bachelor's degree or higher in Biological Science or Bio-engineering from an accredited college or University. Prior experience in technical sales and managing a field coverage area for technical sales or product support. Working knowledge of high-end microscopy, including laser scanning microscopy. Knowledge and experience in biological applications is a huge plus. Good knowledge of MS Office and strong presentation skills. Willingness and ability to travel domestically and internationally, up to 70%. Carl Zeiss offers a competitive salary and excellent benefits. For consideration, please e-mail your resume with salary requirements to: EOE M/F/D/V No Phone Calls Please...

Scientist I, Environmental CGC

CHENEGA GOVERNMENT CONSULTING, LLC Company Job Title: Scientist I Chenega Job Title: Scientist I Clearance: Background Check Location: Atlanta, GA Reports To: Program Manager FLSA Status: Exempt, Full Time, Regular, Salaried Prepared Date: 09-11-2014 Approved Date: 09-11-2014 Summary: The Scientist I will be responsible for production of biological reagents, select agent controls, in vitro diagnostics manufacturing and inventory management. This task will encompass a wide-range of associated duties including, but not limited to the technical requirements Essential Duties and Responsibilities: (Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position) ? Serves as a scientist in the Diagnostic Development and Reagent Production Team responsible for: ? Manufacturing of in vitro diagnostics kits/reagents ? Production of Biological reagents ? Antibody development ? Dispensing of reagents ? Drying/Lyophilization of reagents ? Lyophilization formulation of reagents ? Preparing immunizations ? Purifying sera for antibodies using EKTA prime and explorer ? Making buffers and media ? Performing ELISA ? Performing Western Blots ? Protein Characterization ? Maintaining documentation for batch records ? Write and/or revise SOPs ? Train students and lab personnel on the use of databases, equipment, proper quality assurance, and GMP ? Maintaining mammalian and plant cell cultures ? Select agent microbiological control strains and reagents ? Quality control of reagents produced, this will require basic microbial techniques such as staining cells to running Conventional and Real Time PCR on regents. ? Servicing and maintaining the CDC inventory of biological reference reagents. ? Processing of incoming orders using Inventory management system ? Pulling orders and preparing documentation for shipment. ? Using data management tools to track orders being processed and shipped ? Stocking and maintaining active inventory ? Transporting Inventory between storage sites from Roybal Campus and Lawrenceville Campus. Non-Essential Duties: ? Other duties as assigned Supervisory Responsibilities: ? NONE Minimum Qualifications: (To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.) Bachelor?s degree in a scientific discipline and minimum of two years? experience in a laboratory setting. Knowledge, Skills and Abilities: ? Knowledge of CDC policy and related regulatory training. ? Having Select Agent clearance (SRA approval) ? Basic knowledge of Aseptic techniques when working under a BSC or a laminar flow hood. ? Ability to communicate with scientific and office staff information related to the duties required of the position. ? Ability to lift heavy equipment, boxes, and other laboratory-related items. ? Basic knowledge of computer systems and the ability to enter data when necessary. ? Respiratory medical clearance for N-95 mask and Powered air purifying respirator (PAPR). ? All select agent work will happen in a BSL-3 laboratory which the contractor will need to wear a PAPR. Pathogens that will be worked on in the BSL-3 are Bacillus Anthracis, Brucella species, SARS, and B.Pertussis. Diversity: ? Shows respect and sensitivity for cultural differences; Educates others on the value of diversity; Promotes a harassment-free environment; Builds a diverse workforce. Ethics: ? Treats people with respect; Keeps commitments; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values. Physical Demands: ? The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. ? While performing the duties of this Job, the employee is regularly required to sit and talk or hear. The employee is frequently required to walk; use hands to finger, handle, or feel and reach with hands and arms. The employee is occasionally required to stand; climb or balance and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision. Work Environment : ? The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. ? The employee will normally work in a temperature-controlled office environment, with frequent exposure to electronic office equipment. ? During visits to areas of operations, may be exposed to extreme cold or hot weather conditions. Is occasionally exposed to fumes or airborne particles, toxic or caustic chemicals, and loud noise. Chenega Corporation and family of companies is an EOE. Equal Opportunity Employer Minorities/Women/Veterans/Disabled Native preference under PL 93-638. We participate in the E-Verify Employment Verification Program....

Ballistic Modeling and Effects

Job Classification: Full-Time Regular Numerical Modeling of Reacting Multidimensional Gas/Solid Flows Advisor: Nusca, Michael J. (; 410.278.6108) Key words: Fluid Dynamics, Particle Dynamics , Hypergolic Fuels , Numerical Simulation, Droplet Combustion, Solid Propellant, Reacting Flow, Turbulence, Parallel Computing This opportunity involves the development and application of computational fluid dynamics (CFD) codes that solve the multiphase, three-dimensional, Navier-Stokes equations for chemically reacting gases and burning solid particles. Applications include flows in which all or some of the following effects are important: solid propellant combustion, gas-phase combustion (including hypergolic), equilibrium and finite-rate chemical kinetics, radiation, diffusion, turbulence, vorticity, liquid droplet combustion, porosity, and compaction. Emphasis is placed on performing original research, model generation, and solving practical problems such as those encountered in modeling solid propellant gun charges (interior ballistics), solid propellant rocket engines (internal ballistics), and liquid rocket engines for next-generation missile systems. We encourage the development of original CFD codes and the enhancement of current ARL-generated in-house codes. Computer resources include PC and LINUX workstations, as well as SGI, IBM, and CRAY mainframes. ARL is the site of one of the DOD's Major Shared Resource Centers for high-performance computing. This vast array of computing resources makes the performance of complex CFD simulations feasible. Publications in the open literature and the presentation of papers at appropriate technical meetings and conferences are encouraged. References Schmidt JR and Nusca MJ: JANNAF Journal of Propulsion and Energetics 3(1): 180, 2010 Nusca MJ, et al: Journal of Thermophysics and Heat Transfer 16(1): 157, 2002 Nusca MJ: Journal of Propulsion and Power 18(1): 44. 2002 Nusca MJ, et al: Journal of Advanced Oxidation Technologies 4(3): 271, 1999 Disciplines Sought Ph.D. in Chemical Engineering, Mechanical Engineering, Aerospace Engineering, or similar discipline with Computational Flow Dynamics background Nanoscale Molecular Electronics and Sensors Advisor: SP Karna Key words: molecular electronics, molecular sensors, nanoelectronics, nanodevices, quantum dots and wires, nanophotonics materials, single electron transistor, quantum mechanical theory, surface probe microscopy This research opportunity focuses on developing a fundamental understanding and functional prototypes of molecular and quantum electron devices for applications in nano-electronics and sensors. Research involves developing device concepts, molecular and quantum architectures, and theoretical and experimental characterization of electron transport and quantum conductance of molecular-scale basic electron device elements. Theoretical and experimental investigations are performed to understand (1) physical and chemical mechanisms for controlled transport of electron, static, and dynamic electrical response; mechanism and control of current switching, current amplification, and charge retention in molecular electron devices; (2) dynamics of electron transport at the molecule-solid interface; and (3) operation and performance of three-dimensional molecular-scale nano-electronic device architectures and circuits. The nanosensor research focuses on developing nanoscale molecular sensors for real-time electrical detection of chemical and biological agents. The research involves theoretical and experimental investigation of electrical properties of biotic-abiotic interface, chemical/biological to electrical transduction mechanisms, electrical response of molecule-integrated nanoscale devices, chemical and biological gating of field effect transistors, and interface between molecular and microscopic devices. A major part of this work focuses on developing and establishing test and evaluation techniques, criteria, and metrics for characterizing and validating molecular-scale nano-electronics and sensor devices. State-of-the-art computational and experimental facilities are available. This research is performed in close collaboration with other teams within ARL and in other DOD laboratories. References Woo R, Pati R, Karna SP: Applied Physics Letters 81: 1872, 2002. Pati R, Karna SP: Chemical Physics Letters 351: 301, 2002. Theory and Modeling of Nanophotonic Materials Advisor: SP Karna Key words: molecular electronics, molecular sensors, nanoelectronics, nanodevices, quantum dots and wires, nanophotonics materials, single electron transistor, quantum mechanical theory, surface probe microscopy This research focuses on developing theory, computational techniques, and their applications to model electro-optical (EO) and nonlinear optical (NLO) materials. Theoretical methodologies include first-principles quantum mechanics and molecular dynamics simulations. Calculations are performed to investigate the origin and mechanisms of EO and NLO responses; evolution of properties with the size and geometry; and the relationships between chemical, electronic, and geometrical structures and the EO and NLO properties of nanoscale materials. Materials of interest include functional organic molecules and nanosized atomic clusters of Si, Ge, III-V, and II-IV materials. Excellent facilities exist for algorithm development, testing, and conducting high-performance computations on nanoscale NLO materials. This research is performed in close collaboration with the experimental groups within ARL, Natick Solider Center, and other DOD laboratories. Reference Karna SP: Nonlinear Optics 27: 75, 2001...

Mgr Downstream Validation Scientist Eng

Sanofi Pasteur, the vaccines division of Sanofi, is the largest company in the world devoted entirely to human vaccines. Our driving goal is to protect people from infectious diseases by creating safe and effective vaccines. Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients? needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi Pasteur offers the broadest range of vaccines in the world, providing protection against 20 bacterial and viral diseases. We distribute more than 1 billion doses of vaccine each year, making it possible to vaccinate more than 500 million people across the globe. Our company has more than 13,000 employees worldwide working in 14 production and/or R&D sites with more than 50% of staff devoted to industrial operations (IO). Industrial Operations (IO) at our Swiftwater, Pennsylvania site, the largest vaccine manufacturing facility in the US, continues to develop its manufacturing assets to produce existing and new vaccines and biopharmaceuticals. Sanofi Pasteur provides associates in IO a variety of opportunities to develop and enhance their career through the ability to work in diverse roles across functions, resources for continuous learning, and assistance for those wishing to further their education. Who We Are The Industrial Operations (IO) site at Swiftwater, Pennsylvania, one of the largest vaccine manufacturing sites in the USA, continues to develop its manufacturing assets for existing and new vaccines and biopharmaceuticals. IO provides a variety of development opportunities to our associates on the job through diverse roles across many functions, on-site resources for continuous learning and off-site access to further education. The Position This position of Industrial Operations Manager Associate Process Engineer, in the Manufacturing Technology (Mtech) function of Industrial Operations, participates in the execution of technical studies to industrialize inspection processes for Phase 3 and licensed production. The mission of MTech is to deliver robust and efficient process & testing with associated know-how transfer to Manufacturing & Quality Control (QC). Mtech?s function also provides daily support, for manufacturing and QC, toward industrial performance excellence. Swiftwater IO conducts and optimizes activities in area of specialization with high technical and scientific complexity. The Industrial Operations Downstream Validation Scientist/Engineer is responsible for validation of downstream processes for biomolecules as well as definition of critical process parameters. The individual in this position will contribute to cross-functional teams from various functions in IO to meet project objectives and deliver the following: Accountabilities : ? Provide validated, efficient, safe and regulatory compliant downstream processes for proteins and polysaccharides to manufacturing groups. ? Lead and supervise the design, documentation and execution of investigation, definition, engineering, and process validation studies at bench and manufacturing scales. ? Interpret and communicate study results within the platform or project. ? Provide technical expertise and act as a subject matter expert for downstream process validation including: chromatography, column packing validation of columns greater than 40cm diameter, column and TFF lifetime validation, cleaning, mixing, filter, and process hold step validation. ? Author, train technicians, and execute risk analyses, validation protocols, and reports. The Job Responsibilities Include: ? Apply risk based and Qbd approaches for downstream process validation and process control strategy definition. ? Cooperate transversally and lead cross functional teams to complete validation of efficient and robust downstream processes to the manufacturing groups. ? Design, lead and execute bench scale studies to help define process control and validation parameter ranges. ? Work closely with and lead technicians and teams in support of validation and processing issues. ? Critically design studies and analyze data from complex systems to recommend and present effective problem resolution. ? Implement a hands on approach in leading design and execution of investigational, definition, engineering and validation studies. ? Maintain up to date knowledge in downstream process validation advancements and regulatory trends in order to implement innovative solutions to validation issues. ? Comply with cGMP and other internal and external quality and regulatory guidance. ? Support health authority inspections and follow up actions. ? Comply with health and safety guidelines. Who You Are You are inspired by Sanofi Pasteur?s IO mission to improve worldwide human health, as a reliable manufacturer, by delivering high quality, innovative, and affordable products to our customers. You would fit in well with our Sanofi values of innovation, solidarity, confidence, respect, and integrity and our ways of working (Focus, Agility, Accountability and Simplicity)....

Quality Control Technician - Environmental Monitoring

Kelly Services® has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a long-term temporary opportunity to work as a Quality Control Technician in a prestigious Fortune 500® pharmaceutical company located in RTP, NC. By working with Kelly in this role, you would be eligible for: - A competitive hourly pay rate with weekly checks - Access to newly expanded Medical Plan options - Online continuing education via the Kelly Learning Center - Several employee discounts - And more! This is a 12 month temporary position at 40 hours per week. Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. If you have questions about the position, you may contact the recruiter recruiting for this position ( or call 732-246-1396 x 229). JOB TITLE:Associate I, Quality Control JOB DESCRIPTION:The primary responsibility for a Quality Control Associate I is the execution of QC environmental monitoring, routine testing and all activities associated with executing this testing in a cGMP manner. Additional responsibilities include, but are not limited to, training on multiple assays, basic analytical/technical support and problem solving capabilities, basic writing skills, support of method transfer, support of method qualification and validation activities as appropriate, execution of robust and compliant cGMP documentation practices, and a basic understanding of FDA/EMEA regulations. An Associate I will adhere to the Quality Systems and apply, as appropriate, to daily functions. The Associate I will communicate with the Supervisor/Manager regarding cGMP compliance and identification of issues and/or corrective actions on the laboratory floor. The Associate I will be able to work effectively within the group to promote robust teamwork by having both verbal and written communication skills. The Quality Control Associate I will possess demonstrated technical ability regarding fundamental laboratory techniques and analytical methodology. The position requires but is not limited to the following: Understanding of basic biological science principles; ability to communicate with peers and management; effective organizational skills; ability to multitask and coordinate multiple activities in parallel; developing or demonstrated instrument/method troubleshooting and problem solving skills; general knowledge of FDA/EMEA regulations and compliance. Education B.S. degree biological science preferred; 0-2 years of relevant experience or A.S. degree biological science preferred; 8+ years of relevant experience About Kelly Services ® Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions. Kelly ® offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis. Serving clients around the globe, Kelly provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion. [Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter . Download WorkWire ? , a free career and employment resource iPad® app by Kelly Services.] iPad is a trademark of Apple Inc., registered in the U.S. and other countries. App Store is a service mark of Apple Inc. Our science specialty places professionals to a broad spectrum of industries, including biotechnology, chemical, clinical research, consumer products, biotechnology, consumer products, environmental, food sciences, pharmaceutical, and petrochemical fields. Want more information? Visit kellyservices.com/science Connect with us on...

Water Resources Specialist

Cardno ENTRIX is an environmental and natural resource management consultancy providing a broad suite of services in Water Resources Management, Natural Resources Management, Permitting & Compliance, and Liability Management. Clients turn to Cardno ENTRIX for help navigating complex environmental, natural resource, and business challenges because of our creative problem-solving and the successful track record of our multidisciplinary team. Cardno ENTRIX is seeking a Water Resource Specialist in our Riverview, FL office. Responsibilities include, but are not limited to: > Surface water quality and biological sampling Field investigation and study design > Maintaining sample Chain of Custody > Data entry > Quality Assurance/Quality Control > Report Writing > Laboratory procedures for biological samples...

Senior Biosynthetic Engineer

Responsibilities: The Biosynthetic Engineer will be responsible for projects supporting biology subfields in several industries and to name a few: food, pharmaceuticals, bioproducts, and bioenergy. -Research related to Bio Kinetics to target growth, reduction, elimination, transformation, & measurement of bioorganisms such as yeast, bacteria, and animal cells. -Research related to Bio Molecular aspects, for example genetic elements including DNA/RNA manipulations, biological assays and techniques to successfully create products of interest in the lab or for industrial problem solving. -Strong association with a Specific Industry but association with multiple industries either by education or experience will be considered a plus. As a researcher, the individual will perform the following activities: -Define scientific and technical specifications for research experiments -Be a technical lead and drive innovation in their field of expertise -Take active participation in project planning -Support technical transfer of projects -Prior training (or) willingness to be trained in handling pathogenic/non pathogenic bacterial strains in Class II biosafety lab -Serve as a safety role model, maintaining high safety standards and promoting improvements -Work closely with internal market groups and industry partners or customers -Willingness to travel to internal/external customer sites and AL R&D centers -Play a lead scientific role related to Life Science Biology topics within the organisation -Individuals are expected to have a strong link to academia, associations and industry. Peer reviewed publications or patents to demonstrate their capabilities will be a plus. QUALIFICATIONS: M.S. with minimum 10 years experience or PhD with 5 years experience in related scientific field of Biology or Engineering in chemical/biochemical/biological engineering. Demonstrated ability to bring innovations, improvements, and process modifications from concept to reality. Candidate should have direct experience in several of the following topics: enzyme modification/kinetics, fermentation, bioprocessing, biosynthesis, molecular assays. Must be a self-starter, highly motivated, and work well in a multidisciplinary group. Candidate is expected to have excellent written and oral communication skills. Ability to innovate and generate potential patents in their area of expertise are expected traits of a researcher. Individual should be results-driven while being flexible and able to adapt to changing conditions/priorities. A technical career ladder exists for scientists/engineers to progress their career based on expertise....

Engineering Specialist

The Senior Scientist/Engineer position, Product Development will be working as part of a multi-disciplinary team and be responsible for the development of new consumables in the areas of microfabrication, microfluidics, cell isolation and analysis during feasibility and development. He/She will also be involved in interfacing between the instrument, software and assays in order to refine system requirements and develop the strategy for Integration, System Verification and Validation. The candidate will be independently responsible for the conception, design, implementation and interpretation of scientific research projects pertaining to the fabrication, process development and testing of microstructure based devices for biological analysis. The candidate will be required to conduct experiments on early consumables and prototype/breadboard fixtures in an effort to refine requirements and identify areas of risk and mitigations for those identified areas. Additionally, the individual may be required to assist in similar activities for other subsystem areas depending on the nature and complexity of the feasibility and integration activities. The successful candidate will develop concepts, strategy, test plans/protocols and reports for feasibility and integration activities to be compliant with regulatory requirements, and J&J procedures. He/she will be providing direction to other team members who will be responsible for executing test designs along with the candidate, and performing the data analysis/evaluation to draw conclusions and write reports associated with the activities. This person will be responsible for effectively interacting with people representing a broad array of technical specialties to achieve success. He/She will be responsible for thinking broadly, unconventionally and being open to new ideas from others. Qualifications A minimum of a Master?s degree (PhD preferred) in Biomedical/Chemical/Mechanical Engineering is required. At least 5 years experience working in a laboratory or medical device/diagnostics industry is required. Hands-on experience in microfabrication (soft lithography, hot embossing, molding), microfluidic testing, surface modification, materials processing is required. Experience in MEMS processing, mold fabrication is desired. Experience in cell isolation, biological analysis techniques is a big plus. Experience working under QSR design control processes for Medical Device is a plus. Experience with disposable design for manufacture and commercialization will be important, including an understanding of material and surface properties of polymers and their properties, manufacturing techniques for high precision disposables, quality control and analytical techniques. Must have a strong knowledge of statistics, especially related to Design of Experiments (DOE) and excellent technical writing skills. The successful candidate should possess excellent analytical and critical thinking skills, strong oral/written communication skills, a passion for science, dedication, focus, quick learning abilities, the ability to multitask, and good experiences with interdepartmental and external collaborations....

Principle Quality Engineer Sterilization - Medical Device

Our client is a leading, global Medical Device Manufacturer with an outstanding reputation for developing innovative life enhancing devices. We have been contacted to fill the position of Principle Quality Engineer , Global Sterilization. This position has the responsibility for the compliance of the sterilization programs to meet Corporate standards for sterilization validation NPD for sterilization, product adoption and bio-burden monitoring. Strong, stable company, competitive salary and benefits. Great location! Program Leader in the coordination and maintenance of compliance for all sterilization validation activities. Will be the main contact for product introduction contract supplier approvals, certification maintenance and regulatory submission information regarding sterilization. Perform as the technical lead and oversight for sterilization equipment qualification and re-qualification for contract sterilization suppliers and technical oversight for all sterilization validation programs. Manages department sterilization quality engineers. Lead the execution of the Global Sterilization strategic initiatives for cycle development activities to support product introductions, acquisitions or cost improvement programs. Ensure compliance to divisional, Corporate ISO and EN requirements. Monitor and measure sterilization suppliers. Support and participate in regulatory agency (EPA, JOSHUA,FDA and ISO) visits/audits at all locations supported by Global Sterilization. keywords: quality, sterilization, medical device, management, engineer, biotechnology...

Principal Quality Engineer - Sterilization

Overview: The Principal Quality Engineer - Global Sterilization is located at C. R. Bard Operations, Covington,GA. Summary of Position with General Responsibilities: The Principle Quality Engineer Global Sterilization is responsible for the compliance of the Bard sterilization programs to meet the Corporate standards for sterilization validation, NPD for sterilization, product adoption and bioburden monitoring for C. R. Bard. The Principle Quality Engineer Sterilization is the main contact for product introduction, contract supplier approvals, certification maintenance and regulatory submission information regarding sterilization. Essential Job Functions: Program leader in the coordination and maintenance of compliance for all sterilization validation activities including protocols and reports for all modes of sterilization for all C.R. Bard divisions whose product is sterilized by Bard and/or an approved Bard contract sterilization organization.Ensures compliance to divisional, Corporate, ISO, and EN requirements.Oversees the evaluation of new or modified products for sterilization validation equivalency (adoption) for products sterilized in Regional sterilization and contract suppliers.Leads the management of the Corporate Bioburden program Provides leadership and technical expertise for sterilization related process improvement projects for all C. R. Bard sterilization programs. Performs as the technical lead and oversight for sterilization equipment qualification and re qualification for contract sterilization suppliers. Performs technical oversight for all sterilization validation programs.Manages department sterilization quality engineersLeads the execution of the Global Sterilization strategic initiatives for cycle development activities to support product introductions, acquisitions or cost improvement programs. Oversees the sterilization supplier audit schedule and ensures compliance to schedules.Monitors and measures the quality performance of sterilization suppliers and oversees disposition of process nonconformities to support the business.Supports and participates in regulatory agency (EPA, OSHA, FDA, and ISO) visits/audits at all locations supported by Global Sterilization.Other duties as assigned related to sterilization, compliance or projects to support the C. R. Bard business. ....

Industrial Wastewater Engineer

O'Brien & Gere has become more than an engineering solutions provider throughout our history of creating a better future since 1945. At the center of our story are clients ranging from advanced manufacturers to higher education, federal agencies, and municipalities. These clients trust us to deliver sustainable solutions and integrate innovative technology to solve the evolving energy, water, environmental and facilities challenges of today and tomorrow. By living our mission of People creating a better future by making a difference each day, we are improving natural and built environments for our clients, employees, and communities. And our story keeps getting better? Industrial Wastewater Engineer: O'Brien & Gere currently has an opportunity for an experienced Industrial Wastewater Engineer in our Raleigh, NC office. This position will be responsibility for, but not limited to, the following: Project work associated with private industrial clients such as: Food & Beverage; Industrial Manufacturing; Life Sciences & Pharmaceutical; Facility Remediation / Decommissioning Advanced wastewater and residuals / biosolids treatment process evaluation, process modeling, optimization and operation utilizing processes such as: biological treatment (aerobic & anaerobic); Physical / chemical treatment; Membranes Advanced wastewater treatment plant design for the above mentioned processes (including biological processes for nutrient removal) Applying anaerobic processes for biosolids management and energy recovery Industrial client contact and strategic plan implementation related to technical advice, planning, design, permitting and construction phase services for industrial wastewater engineering projects Plant inspection, process design and selection, regulatory interface, and permit applications, preparation of construction drawings and specifications, client management and project management Delegating technical and administrative responsibilities to engineers, designers and drafters on major and complex projects Maintaining an active role in the selection of the project team, prepares and administers project budgets and schedules for projects under supervision Assisting in the evaluation and selection of project contractors for design-build or CM-at-risk project delivery methods...

Senior Process Engineer - Naperville, IL; Victor, NY; or Dalton, MA

Nalco, an Ecolab Company, has an immediate need for a Sr. Process Engineer located in Naperville, IL. There is flexibility to work from either our Victor, NY or Dalton, MA offices as well. This is your opportunity to join a large growing company offering a competitive salary, bonus structure and benefits. Job Overview: You will be primarily responsible for providing process engineering support within the manufacturing, power, chemical and food & beverage industries. Building solid relationships project developers, colleagues, research & development teams, and other relevant people within the organization will be essential to future success in this role. Territory/Location Information : This position can be based in Naperville, IL; or Victor, NY or Dalton, MA. Each location has a dedicated Ecolab office hub. Relocation assistance would be provided for the right candidate. Main Responsibilities : Development of process flow diagrams, mass balances and other information to describe the specific system requirements for a particular project; Develop relationships with key stakeholders in current and new customers, to also include project developers, R&D, development teams, etc.; Work closely with the Project Developer and current and new customers to understand business needs and recommend continuous improvement and innovation plans interface with sales and engineering teams; Provide technical and troubleshooting support to Project Developers working with customers and Nalco&s Operation & Maintenance group; identifying and resolving customer challenges, related to existing or new wastewater systems; Engage in problem solving by performing system analysis, interpreting data and providing written recommendations in the form of a report or presentation; Up to 20% travel to customer sites will be involved....

Wetland Biologist

Tetra Tech, a leader in consulting, engineering, environmental science and technical services worldwide has a challenging opportunity for a highly motivated professional in our growing Technical Support Services Division. We are a diverse company, embracing talented individuals with expertise in science, research, engineering, construction, and information technology. Our strength lies in collectively teaming together to provide integrated services delivering the best solutions to meet our clients' needs. We currently have an exciting opportunity for a Wetlands Biologist in our growing Portland, Maine operation....

Entry Level GIS Analyst

Tetra Tech, a leader in consulting, engineering, environmental science and technical services worldwide has challenging opportunities for highly motivated professionals in our growing Technical Support Services Division. We are a diverse company, embracing talented individuals with expertise in science, research, engineering, construction, and information technology. Our strength lies in collectively teaming together to provide integrated services delivering the best solutions to meet our clients' needs. Tetra Tech, Inc. is seeking a qualified entry-level GIS Analyst to support work at its Portland, ME office for GIS analysis, geospatial data processing, and figure/map generation for a variety of biological and natural resources programs. The successful candidate will function in a support role under a Lead GIS Manager, and will be responsible for supporting a variety of our natural resources projects. A multidisciplinary science-based background is desired. The majority of work will be office-based. PRINCIPAL DUTIES AND RESPONSIBILITIES: ? Provide a strong and dependable GIS support role for biological field data analysis (e.g. birds, bats acoustic monitoring data). ? Prepare hard copy and electronic figures and field maps in ArcGIS. ? Perform geospatial data management, analysis and documentation. ? Identify published sources and downloading spatial data in support of natural resources projects. ? Compile metadata documentation to FGDC and related standards. ? Perform geodatabase design, maintenance and documentation. ? Collect, download, correct, and export Trimble and Garmin GPS data. ? Potential to assist or perform natural resource surveys (e.g., wildlife, habitat, functional assessments, vegetation, wetlands, aquatic resources, and vernal pools). If you are interested in joining our dynamic team, for immediate consideration submit your resume to Tetra Tech, Inc. CES . Please mention the position you are applying for in your cover letter and include salary requirements. A Pre-employment drug screen is required....

Regional Safety & Health Manager

Conestoga-Rovers & Associates (CRA) provides comprehensive engineering, environmental consulting, construction, and information technology solutions for our clients. With more than 30 years of experience in providing high quality and responsive services, CRA has grown to over 90 offices and 3,000 employees working on projects worldwide. Conestoga-Rovers & Associates has an opening in our Houston, TX office for a Regional Safety and Health Manager with experience associated with Behavioral Based Safety and Health programs, who aspires to become an active employee in a vibrant, well-established company. If you?re driven, fast track your career here ! Responsibilities: Develop and implement health and safety programs and standard operating procedures for the company Implement systems to minimize the potential for employee exposure to chemical, biological and physical hazards Implement procedures for investigating, reporting and controlling occupational injuries and illnesses Implement an audit program to ensure safety program compliance Oversee and implement a specific program (i.e. medical surveillance, training & PPE) program for the company as assigned Evaluate and identify training needs for the company with respect to health and safety Develop, implement and conduct internal employee training programs related to the health and safety program Provide leadership and support to the office safety coordinators, within their respective region Provide project safety support to the offices within their region of responsibility Assist other regional managers with their program requirements as needed...

Environmental Scientist

Global Employment Solutions is actively seeking an Environmental Scientist and Permitting Specialist The ideal candidate will be responsible for: The successful completion of field investigations and resource agency report preparation to support our clients? growing midstream pipeline, facilities, and electric transmission permitting practice Take the lead in integrating environmental requirements into successfully completed projects with independent responsibility to coordinate and conduct ecological and natural resource field surveys (e.g. wetlands; waterways; soils; vegetation; rare, threatened & endangered species) and prepare agency reports and consultation letters A full description is available to qualified candidates....

Production Engineer

The Dow Chemical Company has an exciting opportunity for the right individual to fill the role of Production Engineer located in Seadrift, TX . The Production Engineering role acts as a technical resource for Operations personnel, applying technical skills within Manage Production, to optimize plant operations, resolves plant problems and enables production of low cost, quality products. This role is to provide a technical resource to assist work teams on daily operations and process performance so as to run a low cost, on specification, reliable, optimized operation, thereby maximizing value to the business. The need for and application of this role is determined by the specific Plant/business. Responsibilities Understands all applicable process technology, equipment and control technology. Works with Technical Advising and Operate Plant personnel to optimize operations, meet Business and plant goals (EH&S, quality, production, cost). Participates in advanced troubleshooting and coaches others to learn these skills. Implements best practices in operations in order to optimize operations. Ensures Most Effective Technology (MET) and specific Operating Discipline requirements are in place. Performs appropriate Manage Production roles as determined by Plant / Business (Operate Plant, Operating Discipline, Produce to Plan / Record Production, etc.). Understands and applies skills and knowledge in Statistical Process Control (SPC) technology to maximize plant asset utilization and produce low cost, quality products. Initiates changes to Plant Operating procedures to ensure they are valid and up to date. Works with Production Technicians in this respect. Networks with other engineers on site and within the global business to leverage knowledge on plant operations (production, improvement, etc.). As required, communicates technical information and issues to plant personnel, technology or expertise centers. As required, participates on and leads teams in his/her area of accountability....

Production Engineer

The Dow Chemical Company has an exciting opportunity for the right individual to fill the role of Production Engineer located in Seadrift, TX . The Production Engineering role acts as a technical resource for Operations personnel, applying technical skills within Manage Production, to optimize plant operations, resolves plant problems and enables production of low cost, quality products. This role is to provide a technical resource to assist work teams on daily operations and process performance so as to run a low cost, on specification, reliable, optimized operation, thereby maximizing value to the business. The need for and application of this role is determined by the specific Plant/business. Responsibilities Understands all applicable process technology, equipment and control technology. Works with Technical Advising and Operate Plant personnel to optimize operations, meet Business and plant goals (EH&S, quality, production, cost). Participates in advanced troubleshooting and coaches others to learn these skills. Implements best practices in operations in order to optimize operations. Ensures Most Effective Technology (MET) and specific Operating Discipline requirements are in place. Performs appropriate Manage Production roles as determined by Plant / Business (Operate Plant, Operating Discipline, Produce to Plan / Record Production, etc.). Understands and applies skills and knowledge in Statistical Process Control (SPC) technology to maximize plant asset utilization and produce low cost, quality products. Initiates changes to Plant Operating procedures to ensure they are valid and up to date. Works with Production Technicians in this respect. Networks with other engineers on site and within the global business to leverage knowledge on plant operations (production, improvement, etc.). As required, communicates technical information and issues to plant personnel, technology or expertise centers. As required, participates on and leads teams in his/her area of accountability....

Manager Associate Scientist Engineer

Sanofi Pasteur, the vaccines division of Sanofi, is a global company that provides more than one billion doses of vaccine each year, making it possible to immunize more than 500 million people across the globe. A world leader in the vaccine industry, Sanofi Pasteur offers the broadest range of vaccines protecting against 20 infectious diseases. The company's heritage, to create vaccines that protect life, dates back more than a century. Every day, the company invests more than one million Euros in research and development. Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients? needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Manager Associate Process Engineer Who We Are Industrial Operations (IO) at our Swiftwater, Pennsylvania site, the largest vaccine manufacturing facility in the US, continues to develop its manufacturing assets to produce existing and new vaccines and biopharmaceuticals. Sanofi Pasteur provides associates in IO a variety of opportunities to develop and enhance their career through the ability to work in diverse roles across functions, resources for continuous learning, and assistance for those wishing to further their education. The Position: This position of Industrial Operations Manager associate scientist/engineer, in the Manufacturing Technology (Mtech) function of Industrial Operations, participates in the execution of technical studies to develop, improve and troubleshoot fermentation processes for Phase 3 and licensed production. The mission of MTech is to deliver robust and efficient process & testing with associated know-how transfer to Manufacturing & Quality Control (QC). Mtech?s function also provides daily support, for manufacturing and QC, toward industrial performance excellence. Swiftwater IO conducts and optimizes activities in area of specialization with high technical and scientific complexity. The Industrial Operations Manager associate scientist/engineer performs hands-on fermentation development, optimization and industrialization. The individual in this position will contribute to cross-functional teams from various functions in IO to meet project objectives and deliver the following: Accountabilities: Provide technical support for the design/maintenance of manufacturing processes Execute investigational, engineering, definition and process validation runs Contribute to the definition of critical process attributes for process validation Communicate and interpret documented study results within the platform or project Provide technical expertise on fermentation / harvest within area of responsibility Author, train, and/or implement instruction on new/improved processes to appropriate audience The Job Responsibilities Include: Work closely with other members of the department to share knowledge and competencies encouraging individual growth and to help ensure the success of company goals. Technical contributor to day-to-day preparation, execution and basic analysis of fermentations for troubleshooting non-conformance occurrences in manufacturing . Perform investigations required for the completion of project deliverables. Critically analyze data from complex systems and recommend efficient courses of action for resolution. Responsible to deliver technical solutions to meet project deliverable timelines. Maintain up to date knowledge in technological advancements and regulatory trends applicable to the area of expertise. Propose applications of new technologies to currently existing platforms to improve productivity, throughput, purity, quality and/or compliance. Comply with CGMP and other internal and external quality and regulatory guidance. Contribute to health authority inspections and follow up actions. Who You Are Sanofi Pasteur?s IO mission is to improve worldwide human health, as a reliable manufacturer, by delivering high quality, innovative, and affordable products to our customers. You would fit in well with our Sanofi values of innovation, solidarity, confidence, respect, and integrity and our ways of working (Focus, Agility, Accountability and Simplicity)....

Manufacturing Engineer

We have an immediate need for a Manufacturing Engineer JOB DESCRIPTION This Manufacturing Engineer will provide incremental Manufacturing Engineering support while the client transfers from a legacy Material Resource Planning application (BPCS) to a new system (SAP). This will involve updating Manufacturing routers and Bills of Materials, executing Engineering Changes and backfilling for other engineers as they support this major effort for a large biological product manufacturing site. It will also include participating in steps to ensure successful transfer of data. A BS in Industrial Engineering, Mechanical Engineering or Chemical Engineering is required, as is at least 2 years of related experience. CDI Corporation is an EEO/An Affirmative Action M/F/D/V Employer...

Director of Engineering

SlipChip Corporation is a next generation microfluidics company with a proprietary platform designed to make highly quantitative measurements of nucleic acids and proteins with minimal capital equipment. This revolutionary platform is capable of performing standard PCR, RT-PCR and digital PCR measurements and multiplexed reactions in traditional laboratory, clinical and limited resource settings (LRS). We are seeking candidates who are self-driving and like to work with highly motivated people in a creative, collaborative and friendly environment. Job Description: Innovation is a central to this role. The company seeks to develop ground breaking first to market technology. The Director of Engineering will lead a team focused on discovering and improving the company?s technology that will be directed towards a wide range of applications. Lead engineering group for execution of company product priorities. Manage department budget, hiring and project priorities and deliverables. Provide project updates to executive team and BOD as warranted. Support assay and applications group for development and manufacturing transfer of automated sample preparation device. Interface with internal regulatory group and outside agencies, as required, to assure compliance with regulations as part of the development and commercialization of the companies intended clinical diagnostic products....

Applications & Technical Support Specialist II

Carl Zeiss Microscopy, LLC, located in Thornwood, New York, provides industry-leading and innovative microscopy and imaging solutions for bioscience, materials and industrial research, educational and routine microscopy. Carl Zeiss Microscopy is a provider of key enabling technologies in both high tech industries and life sciences research. We are uniquely positioned to play a major role in helping our customers find the answers to the most pressing challenges of biological and material science. Applications & Technical Support Specialist II - Albuquerque, NM Primary Duties & Responsibilities: Operate a new type of electron microscope (MultiSEM) which is specifically developed for high throughput applications at a customer site. Offer "real-time" support, oversight & training of the system installation process. Facilitate existing training programs in accordance with defined curriculums and objectives. Support all sample runs for a 6-months to a specific customer. Lead effort to improve both existing and new product quality, reliability & serviceability. Responsible for coordinating all after-install activities. Education & Experience: BS in technical/scientific discipline, or an equivalent combination of training and experience. 5+ years direct experience building, maintaining, installing, and/or repairing Carl Zeiss Microscopy systems or similar complex electromechanical systems. Superior troubleshooting skills & ability to diagnoses complex system problems. Demonstrated understanding of analog & digital electronics, optics, chemistry, pneumatics, & vacuum systems . Superior communication skills, both verbally and in writing. Knowledge of Windows OS, & microscopy applications. Carl Zeiss offers a competitive salary and excellent benefits. For consideration, please e-mail your resume with salary requirements to: EOE M/F/D/V No Phone Calls Please...

Chief Engineer

JOB SUMMARY: The Chief Engineer is responsible for safely operating, maintaining, modifying, and repairing the client?s base building and laboratory systems and equipment; such as HVAC, controls, plumbing , and laboratory related systems and equipment. Supervisory responsibilities of a five person crew are also included, as well as completing one?s own work tasks assigned. ESSENTIAL FUNCTIONS & RESPONSIBILITIES: SUPERVISORY RESPONSIBILITIES: Lead. Direct, and coordinate the DTZ Operations & Maintenance staff Performs all assignments in accordance with DTZ?s approved procedures Work with the DTZ Planner/Scheduler to utilize the CMMS in order to coordinate and track resources/expenditures for all work performed HVAC Equipment Maintenance, Repairs and Inspections Maintain HVAC and plumbing equipment as part of the facilities preventive maintenance program Respond to all Hot/Cold calls and execute monitoring of space temperatures Conduct necessary troubleshooting and testing of equipment to determine root cause of breakdown; remove and replace faulty parts, and major components; and make adjustments for proper operation Install, repair, adjust, service and maintain control systems used for building HVAC Laboratory Equipment Maintenance, Repairs and Inspections Vacuum system and pumps Reverse Osmosis De-ionized water system pH Neutralization System Fume Hoods / Biological Safety Cabinets Pressurized gas piping systems Energy Management and Conservation Familiarization with Building Automation Systems Operate, evaluate, and set efficient parameters for the energy management systems to achieve maximum efficiency and cost savings Continually evaluate new equipment and ideas to maximize efficiency and cost savings Plumbing Repair and Maintenance Repair restroom fixtures such as; faucets, urinals, toilets etc. Domestic Water Pumps Provide labor and equipment necessary to attempt to unclog sewage and drain lines General Maintenance Supervise/Coordinate DTZ general maintenance staff Repair, replace, or adjust inoperable interior doors and closers Replace damaged, stains, or missing ceiling tiles Replace damaged VCT floor tile Refasten existing or replace damaged cove base Hang bulletin boards, writing boards, and pictures Patching and painting interior walls and surfaces Minor rug repair Moves-Adds-Changes Supervise / coordinate DTZ Utility staff Support client employee workstation moves/alterations Additional Responsibilities could include: Ordering of necessary parts and supplies for maintenance work Perform weekly test and inspection of all emergency generators Maintain compressors, air dryers, and supervisory equipment alarms Perform other related duties as assigned such as snow removal, assisting other tradesmen, and emergency repairs Assist in the development and administration of Standard Operating Procedures OBJECTIVES: Safety ? perform work safely without injury Utilize all safety practices appropriate to the work being done Attend, pay attention and participate in safety meetings and training Observe and promptly report safety violations/unsafe conditions in the work area to management Use fall protection equipment and work on elevated areas Workmanship ? complete work in a professional, high quality manner Fix the problems Use the appropriate materials and tools Use the appropriate amount of time Clean up afterwards P rocessing paperwork timely and complete Closeout work orders with time, expenses, and comments on day work is completed Fill out purchase requisition for all purchases DTZ required documentation Customer satisfaction - create customer satisfaction with work performed Perform work requested in time allotted Communicate completion of work REQUIREMENTS (Knowledge, Skills, Abilities, and Education and/or Experience): Must possess a MA Refrigeration mechanic license and be certified for CFC refrigerant recovery Completed an apprentice program and/or graduated from a certified HVAC trade?s school Must be familiar with Plumbing codes Ability and willingness to work off hours if necessary, evenings, and nights as well as overtime, weekends and holidays, as required Must possess a high school diploma or an approved GED WORKING CONDITIONS and/or PHYSICAL REQUIREMENTS: The employee works both inside and outdoors and is exposed to changing conditions. The employee frequently works near moving mechanical parts, and exposed to wet and /or humid conditions. Occasionally works in high precarious places. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Employee must be able to frequently lift and/or move 50 pounds and occasionally lift and/or move up to 100 pounds. EEO/M/F/VET/Disabled...

Engineer 1/2 - Industrial Wastewater

Woodard & Curran is an 800-person, integrated engineering, science, and operations company. Privately held and steadily growing, we serve public and private clients nationwide. We consistently rank among the top firms in the U.S., including Engineering News-Record's top 100 environmental firms and top 200 design firms. Woodard & Curran was founded with a simple business concept: if we provide an enjoyable place to work with opportunity, integrity, and commitment, we will attract talented people who thrive and excel at their work. Responsibilities: We are seeking motivated and energetic individuals to fill an Industrial Wastewater Engineer 1/2 position in our Duluth, GA office. The ideal candidates must be detail oriented, have a professional demeanor, possess strong organizational skills, and have the ability to work on multiple projects and priorities in a fast-paced environment. The successful candidates will have an understanding of the engineering concepts associated with physical, chemical, and biological processes in wastewater treatment and will provide support to Mid and Sr. Level Industrial Wastewater Engineers in many of the following areas: planning, design and construction of industrial wastewater treatment systems, including assisting with bench-scale and pilot scale process testing, cost estimating, field inspections, construction oversight and start-up. Some travel is required. Qualifications: * B.S. in Civil/Environmental, Mechanical or Chemical Engineering (M.S. preferred). * 2-5 years experience; environmental consulting experience preferred. * Design and engineering experience in wastewater, water or related fields preferred. * EIT preferred. * Excellent writing, communication and interpersonal skills. * Organized and detail oriented. * Positive Attitude. * Ability to work both independently and within teams. * Proficient in Microsoft Word & Excel. * AutoCAD and Microsoft Project skills preferred. * Driver license required. Woodard & Curran is an equal opportunity employer. Woodard & Curran is a Drug Free Work Place. Individuals with Disabilities and Protected Veterans are encouraged to apply....

RCA GIS/IT Database Manager

The Western Regional Conservation Authority (RCA) is seeking an RCA GIS/IT Database Manager to join their team! Incumbents in this class provide an administrative and technical foundation for environmental problem solving and Multiple Species Habitat Conservation Plan (MSHCP) execution; through creation, implementation and maintenance of geospatial databases to managing IT database and systems to meet policy requirements. Incumbents perform complex geographical and financial analysis by developing models to address the impact of population and urban development as it relates to the MSHCP. This involves working in cooperation with and in support of the California Department of Fish and Wildlife, the U.S. Fish and Wildlife Service, environmental groups and consultants to ensure accurate identification of target conservation acreages, generate quantitative data for biological analyses, reach pre-defined goals as set forth in the MSHCP, create and protect linkage to existing Reserves and assure conservation of 146 focused species and their habitats. Competitive candidates will be technical experts in utilizing the most complex GIS applications, programs, and software, including ARC GIS, ARC Info, and ARC SDE. Experience working directly with high level federal, state, and local government officials regarding GIS mapping and database systems. EXAMPLES OF ESSENTIAL DUTIES: (Depending on the area of assignment, duties may include, but are not limited to, the following): ? Supervise, assign, review, and evaluate the work of professional GIS staff performing GIS database administration work; plan, organize, and provide opportunities to develop and maintain job-related competencies. ? Define GIS database information, access and file structure requirements through discussions with users and colleagues. ? Design and implement GIS database management system by creating models, building table structure, establishing referential integrity and preparing documentation. ? Maintain GIS databases by performing database management system backups and recovery including off-site storage for disaster recovery; maintain databases by tuning, monitoring data integrity and security, and resolving problems. ? Organize and transform source documents and data into formats compatible for input into GIS databases and maps. ? Monitor quality and progress; coordinate development, maintenance, and implementation of new or on-going GIS applications. ? Perform the most complex GIS related duties requiring extensive and thorough professional proficiency with GIS database systems; manage a portfolio of short- and long-term projects. ? Create and maintain data warehousing and data mining systems; design and maintain database software configuration library, specifications, documentation, and operating procedures. ? Research, evaluate and test proposed products, product versions and systems solutions. ? Develop quality standards based on industry standards and evaluation of available technology and resources. ? Establish and maintain effective working relationships with staff, departments, agencies, and the public; ensure customer satisfaction and work productivity....

Principal Validation Engineer

Responsible for ensuring the quality of all ASPEX facility systems through execution of validation activities including:? Writing and executing protocols and test cases for validations.? Coordinating testing and documentation of projects.? Identifying exceptions, performing effective root cause analyses, and implementing effective corrective actions? Assisting/leading training for systems.? Writing validation final reports. Responsible for planning and executing multiple assigned validation activities simultaneously, which may include automation, mixing/cleaning, environmental, media program, filter sterilization, autoclave, SIP, VHP, ETO and gamma sterilization, as well as significant projects for new lines, new products or process improvement. Other responsibilities include completing all validation-related documents required which meet all internal and external regulations to support product submissions; evaluating state of the art equipment, processes, and implementing changes as needed; providing scientific/technical expertise for process improvements and innovative approaches to production and validation activities, including technical improvements and utilization of labor, raw materials and equipment; and participating in establishment resource requirements and executing assigned validation activities within the budget limitations. Refer to Annual performance target setting Supports implementation and continuous improvement of a comprehensive validation program at the ASPEX aseptic manufacturing facility to assure compliance to all facility SOPs, corporate standards, and applicable regulatory guidance. Serves as subject matter expert for one or more validation topics that may include steam/EtO/VHP sterilization (including SIP), cleaning validation (including CIP), or process validation. Demonstrated ability to defend subject matter with internal and external auditors. Thorough knowledge of applicable validation regulatory guidance to validation subject matter (e.g. GMPs, sterilization, cleaning validation, process validation) Experience with validation of automated systems preferred. Experience using Kaye validators preferred. Position requires previous experience writing master plans, validation protocols, requalifications, technical reports, and specific validation procedures. Ability to independently lead validation-related projects with minimal supervision and appropriate escalation of issues. Diversified knowledge of applied Statistical Analysis techniques, procedures and criteria to carry out measurements, process, and product capability study toward the development of new or refined equipment, materials, processes, instruments, and products. Ability to function effectively as a member of a team. Self-motivated. Excellent conflict resolution/negotiating skills: must work with other departments to achieve objectives, when schedule conflicts occur able to resolve. Ability to communicate effectively in written and verbal form. Strong, concise technical writing skills required....

Manufacturing Supervisor

The Dow Chemical Company has an exciting and challenging opportunity available for a Manufacturing Supervisor. This opportunity is within the Fabrication department of Dow Water?s Reverse Osmosis Site in Edina, MN. Under the supervision of the Edina Site/Production Leader, the Manufacturing Supervisor is the first level supervisor of a team of approximately 80 shift operators. The Manufacturing Supervisor has shared responsibility and accountability for a section of the plant assets, its personnel and the achievement of the plant goals. The main responsibilities of the Fabrication Manufacturing Supervisor are: Maintaining an accident free work place through the use of Dow?s Environmental Health & Safety (EH&S) processes. Ensuring that the quality of products fabricated meet our specifications. Meeting the Production Schedule as defined in the S&OP Process. Completing the requirements of the Performance Management process for his/her team, including goal setting, coaching and individual development. Working with the Site/Production leader to develop and deliver operations goals and objectives for his/her section. Ensuring that the work processes such as Operating Discipline, Operate Plant, and the Management Systems used in the section are effectively being followed. Driving a culture of empowerment, ownership, recognition, and open dialogue in his/her section. Serving as a change agent in his/her section. Is a part of the Site leadership team. Has responsibility for the control of conversion costs in the section. Continuous improvement in EH&S, Quality, Productivity, Cost through the use of LEAN and Six Sigma tools. May act as a back up to the Site/Production Leader May be assigned specific roles that cover multiple sections of the fabrication area. The Successful Candidate will have: Strong ability to lead change Strong leadership skills Ability to train and motivate personnel in order to balance staffing strength with profitability and growth Strong communication skills - both verbal & written Effective interpersonal skills Must be capable of making independent decisions and judgments based on process experience and mechanical knowledge Strong organizational skills including document management, tracking, result follow-up Strong analytical and problem solving skills Due to the shift schedules at the site, the Manufacturing Supervisor is expected to cover weekends and night shifts as necessary to be able to safely and effectively manage their section....

Engineering/Laboratory Associate

Harvest Technical Services is seeking an Engineering/Laboratory Associate for our San Francisco Bay Area Biotech client. Duties The successful candidate will support new product design, development and implementation of delivery devices and novel injection tools/aids for biologic therapeutics. Primary technologies include auto-injectors, basal infusers/pumps, and needle stick prevention devices utilizing pre-filled syringes and cartridges. Major responsibilities will include the execution of mechanical and analytical testing to support the selection, design verification, commercialization and marketing of various designs. This will include the execution of routine and on-going R&D stability testing, design verification testing, complaint investigations and special testing requests. He/she will work with design engineers and the laboratory manager to identify, develop, implement, qualify and validate new testing equipment and methods to meet capability and capacity needs of the Device Development department, manage laboratory inventory, maintain equipment calibration and qualification status, troubleshoot equipment failures, and ensure sample traceability and data integrity. The person will provide input and execute plans to maintain and improve laboratory safety. The successful candidate will be able to support the design engineer in data analysis and interpretation, to identify questionable results and identify root cause....

PROCESS DEVELOPMENT ENGINEER II / III

Job is located in San Diego, CA. PROCESS DEVELOPMENT ENGINEER II / III Simply Biotech specializes in recruiting exclusively for San Diego's biotech community. We are currently seeking a Process Dveelopment Engineer II/III for a leading and growing San Diego biotech firm. The qualified Manufacturing Engineer II/III will be responsible for downstream process characterization of the current cGMP plasmid DNA manufacture process. In addition, he or she will be responsible for development of scale-up manufacture of plasmid DNA for commercial manufacture. The candidate will be required to work independently in the laboratory and supervise technicians. He or she will be responsible for designing and implementing experimental protocols, interpreting experimental results and preparing internal reports summarizing the results in a regulatory agency format....

Environmental Technician

The Environmental Technician is responsible for the performance of tasks associated with hazardous waste clean-up, site-remediation, equipment decontamination and handling of hazardous materials. RESPONSIBILITIES: * Ensure Health and Safety is the number one goal by following policies, processes, and acting in a safe manner at all times. * Engage in strenuous physical labor including lifting, pulling and pushing heavy objects. * Operate light and heavy equipment including, but not limited to: pumps, vacuum, equipment, oil spill boom, generators, bobcats, etc. * Performs emergency response activities including, but not limited to chemical and water spills, etiological and biological contamination, tank cleaning, equipment decontamination, etc. * Completion of associated paperwork, including but not limited to daily worksheets, vehicle inspections, equipment inspections and Health and Safety requirements and permits. * Quick and immediate response when on call, secure coverage for shift and communicate your replacement's name to the coordinator. * Vehicle inspections, equipment inspections and Health & Safety inspections. Ensures proper use of equipment and immediately notifies supervisor of any mechanical failures or problems with equipment. * Adheres to and ensures constant compliance with Health & Safety Compliance and regulations. * The ability to wear and properly use a variety of Levels A, B, C & D personal protective Equipment (PPE) including respirators, skin, face, hand and foot protection in a multiple number of combinations. * May direct the work of the Field Technician I. * Assist in the field sampling activities and calibration of meters. * Because of the emergency response and operational nature of the position, a continuing condition of employment is that the applicant/candidate acknowledges and agrees to be on-call 24 hours a day, 7 days a week, 365 days a year and on occasion will require work during week-ends and holidays. * Perform other duties and tasks as assigned from time to time by management and will be required by the needs of the Clean Harbors business. REQUIREMENTS: * High School diploma or equivalency. 2 or 4 year degree in Environmental Studies preferred. * 2+ years construction field or related experience. * Complete confined space entry (CSE) and 40 Hour OSHA Training. * Clean Driving record, for the purposes of CHESI, includes: No more than 2 moving violations in the past 3 years; No DUI/DWI in past 3 years; No preventable accidents in the past year; No more than 2 preventable accidents in the last 3 years; No serious moving violations in past 3 years, i.e., Reckless driving, Driving to endanger, Open alcohol containers, etc. * Clean driving record and a valid drivers license required as a continuing condition of employment. * Knowledge of RCRA requirements/regulations. * Attention to detail and perform multiple tasks. * Ability to work with little or no direct supervision and an aptitude to complete assigned work. * Understands the manpower and equipment required to complete assignments * Knowledge of chemicals preferred. * Knowledge of Department of Transportation (DOT) regulations, Environmental Protection Agency (EPA) waste codes, manifesting and Land Disposal Restrictions (LDR) preferred. * Strong mechanical ability. * Demonstrated leadership ability. PHYSICAL REQUIREMENTS: * Position involves strenuous physical exertion; Available for 24 hour, on-call basis. * Able to travel, work weekends, will wear a pager * Requires standing, lifting up to 50lbs., pulling/pushing, carrying, grasping, reaching, crawling, stooping and crouching in confined spaces. * Requires walking, climbing, speaking, listening, color determination and clarity of vision at 2 feet or more (with or without lenses). * Requires sitting. Requires the ability to properly wear and use personal respirator equipment and other forms of personal protective equipment (PPE) including levels A,B,C,D & E, including full encapsulation PPE suits which can elevate body temperature substantially during strenuous exertion. About Aerotek: Aerotek, headquartered in Hanover, Md., is a leading provider of technical, professional and industrial staffing services. Established in 1983, Aerotek is an operating company of Allegis Group, the largest provider of staffing services in the U.S. Aerotek operates a network of more than 200 non-franchised offices throughout the U.S., Canada and Europe. For more information, visit Aerotek.com ....

Field Support Engineer - SCIL No NJ / NYC Metro

Expectation for all Associates: Supports the company's mission, vision, and values by exhibiting the following traits: Trust, Respect, Accountability, Innovation, Teamwork and Servant Spirit. These TRAITS provide a reference for CSA Associates to continually return to as a guide for decision making and a unifying standard for setting priorities and taking action. Position Summary: Re s pon s i b i l i t i e s for this position include the performance of validation, preventative maintenance, calibration and repair tasks on a variety of laboratory instruments and equipment along with associated facility and computer systems. This work is performed onsite at chemical and biological laboratory client facilities. Responsibilities also include the development and implementation of validation, preventative maintenance, calibration, and repair programs for client and internal use. Programs consist of documented procedures, templates, part lists and training modules as well as custom spreadsheets for compiling and analyzing technical data. Program leaders provide expertise support for other CSA Soliance engineers and technicians....

Professional Environmental Engineer II

Professional Environmental Engineer II (Req#178612) Bureau of Air. Supervises a team of engineers/scientists for review of routine to extremely complex air construction and operating permit applications. Reviews applications to ensure they are complete and adhere to all federal and state regulations. PSD applications are coordinated with technical staff to ensure compliance with national ambient air quality standards. Represents KDHE regarding permit application activities, which can include meetings and discussions with EPA, public and private officials, and engineering consultants. Permits are drafted using scientific expertise, interpretation of laws and regulations and conferring with consulting engineers to ensure permits adhere to federal & state air requirements. Participates in public notice process and public hearing process, if needed, which may include discussions with the public, industries, federal, state, and municipal officials. Works with the EPA to ensure that all statutory, regulatory, and procedural requirements have been met. Coordinates assigned activities and provides professional guidance to meet established permit deadlines and priorities. HOW TO APPLY: The application process has 3 STEPS. STEP 1: Register by completing the online Personal Data Form (https://admin.ks.gov/services/state-employment-center/sec-home/state-employment/register-personal-data) (Skip this step if you already have an Applicant ID number.) STEP 2: Complete the State of Kansas Application Form (https://admin.ks.gov/services/state-employment-center/sec-home/state-employment/apply) and submit to the Kansas Department of Health and Environment STEP 3: Email these additional required documents to Include the job requisition number and your last name in the subject line. ? Resume ? Letter of Interest ? Copies of Official transcripts if a degree is required or preferred ? Kansas Tax Clearance Certificate KANSAS TAX CLEARANCE CERTIFICATE REQUIRED: Each applicant applying for a State of Kansas job vacancy must obtain a valid Kansas Certificate of Tax Clearance by accessing the Kansas Department of Revenue's website at http://www.ksrevenue.org/taxclearance.html A Tax Clearance is a comprehensive tax account review to determine and ensure that an individual's account is compliant with all primary Kansas Tax Laws. A Tax Clearance expires every 90 days. All applicants, including current state employees, are responsible for submitting a valid certificate with all other application materials to the hiring agency. This is in accordance with Executive Order 2004-03. If you need assistance with the tax clearance, please contact 785-296-3199....

Engineer 1 - Industrial Wastewater

Woodard & Curran is an 800-person, integrated engineering, science, and operations company. Privately held and steadily growing, we serve public and private clients nationwide. We consistently rank among the top firms in the U.S., including Engineering News-Record's top 100 environmental firms and top 200 design firms. Woodard & Curran was founded with a simple business concept: if we provide an enjoyable place to work with opportunity, integrity, and commitment, we will attract talented people who thrive and excel at their work. Responsibilities : We are seeking a motivated and energetic individuals to fill entry-level Industrial Wastewater Engineer positions in our Atlanta, GA office. The ideal candidates must be detail oriented, have a professional demeanor, possess strong organizational skills, and have the ability to work on multiple projects and priorities in a fast-paced environment. The successful candidates will have an understanding of the engineering concepts associated with physical, chemical, and biological processes in wastewater treatment and will provide support to Mid and Sr. Level Industrial Wastewater Engineers in many of the following areas: planning, design and construction of industrial wastewater treatment systems, including assisting with bench-scale and pilot scale process testing, cost estimating, field inspections, construction oversight and start-up. Some travel is required....

Supervisor / Quality Assurance Technician / Operator

Do you love craft beer and cider? Do you want to craft a career in this fast growing segment of the alcoholic beverage marketplace? Things are happening fast in craft cider and Vermont Hard Cider Company, LLC maker of Woodchuck Hard Cider is leading the charge into deeper innovation in the craft category. We are seeking passionate and energetic people with a love for craft beverages, and Woodchuck, to join the team at our new state-of-the-art cidery in Middlebury, Vermont. Production Supervisor- 2 nd Shift -The supervisor will use proven supervisory skills to direct and train the production team, and to coordinate shift activities. Responsibilities include machine set-up, operating, troubleshooting, and all other aspects of production. Performing preventative maintenance and repairs, troubleshooting, and collecting analytical samples. Quality Assurance Lab Technician ? 2 nd Shift - The Technician performs and interprets analytical lab tests and will ensure the production of hard cider complies with GMP, food safety and company specifications. This includes quality inspections and analysis of incoming raw materials and ingredients, inspecting and troubleshooting equipment, and training staff. The technician will use a B.S. Degree in a Biological Science plus two years of experience, or equivalent, plus basic statistics to calculate control limits, standard deviations and population samples. Production Can Line Lead Operator ? 2 nd Shift - The Can Line Lead Operator is responsible for overall operation of our canline, with Lead responsibilities during 2nd shift. The Lead Operator will setup and operate equipment, coordinate team, and ensure efficient production. Production/Sanitation Operator ? 3 rd Shift - Responsibilities include disassembling, cleaning, sanitizing then reassembling Production equipment in accordance with procedures; performing environmental cleaning in the Cellar, Production, Lab and Warehouse. The Operator will perform basic preventive maintenance and repairs of equipment and will maintain tools and equipment. Production Operator ? 2 nd Shift - Responsibilities include setting up and operating production machines each day, inspecting equipment and product, and will perform basic preventive maintenance and repairs of equipment and will maintain tools and equipment. Brewery or Cidery experience is ideal! General qualifications include a High School Diploma, with volume and calculation skills, the ability to troubleshoot basic mechanical issues and to lift 35 pounds. Two years of production experience, and computer skills are preferred. Vermont Hard Cider Company provides a strong total compensation package, including insurance coverage?s, 401(k) plan and paid time off. Apply online at www.woodchuck.com . EOE...

Environmental Technician I - Benicia,CA

Job ID: 35541 Position Description: Clean Harbors is the leading provider of environmental, energy and industrial services throughout North America. The Company serves a diverse customer base, including a majority of the Fortune 500 companies, thousands of smaller private entities and numerous federal, state, provincial and local governmental agencies. Through its Safety-Kleen subsidiary, Clean Harbors also is a premier provider of used oil recycling and re-refining, parts washers and environmental services for the small quantity generator market. Headquartered in Norwell, Massachusetts, Clean Harbors has waste disposal facilities and service locations throughout the United States and Canada, as well as Mexico and Puerto Rico. We offer competitive salaries and progressive benefits including health, dental, life insurance, 401K, generous paid time off, tuition reimbursement and more. We offer a drug free work environment and require a pre-employment drug screen. All Applicants are subject to pre-employment security background checks, and some positions may require pre-employment physical fitness for duty tests. The Environmental Technician I is responsible for the performance of tasks associated with hazardous waste clean-up, site-remediation, equipment decontamination and handling of hazardous materials. At times, must be able to work with little or no supervision. RESPONSIBILITIES: ? Ensures Health and Safety is the number one goal by following policies, processes, and acting in a safe manner at all times. ? Engage in strenuous physical labor including lifting, pulling and pulling heavy objects. ? Operates light and heavy equipment including, but not limited to: pumps, vacuum equipment, oil spill boom, generators, bobcats, etc. ? Performs emergency response activities including, but not limited to chemical and water spills, etiological and biological contamination, tank cleaning, equipment decontamination, etc. ? Quick and immediate response when on call, secure coverage for shift and communicate your replacement's name to the coordinator. ? Handles various hand tools and powered (pneumatic and electrical, hydraulic) industrial tools, including pressure washers and saws. ? Works with vibration-producing tools including jack hammers, rivet-busters, air-chisels, nibblers and etc. ? Ensures proper use of equipment and immediately notify supervisor of any mechanical failure or problem of equipment. ? Adheres to and ensures constant compliance with Health & Safety Compliance and regulations. ? Wear and properly use a variety of Levels A, B, C & D personal protective Equipment (PPE). This includes respirators, skin, face, hand and foot protection in a multiple number of combinations. ? Works in various temperatures indoors and outdoors in all weather conditions: including extreme heat and cold while wearing various levels of personal protective equipment. ? Works in atmospheres and locations with the potential for exposure to various chemical and physical agents, some of which may be hazardous, toxic or corrosive. ? Works in potentially elevated noise levels, confined spaces, including lifting in areas of low clearance. Working at elevations including working from ladders and scaffolding. ? Assists in field sampling activities and calibration of meters. ? Climbs ladders, scaffolding and into and out of trucks, tanks, and various other containers. ? Works extended (> 8 hrs.) time periods. Note that in emergency response situations these periods can extend beyond 8 hours, up to 12-24 hrs.; Because of the emergency response and operational nature of the position, a continuing condition of employment is that the applicant/candidate acknowledges and agrees to be on-call 24 hours a day, 7 days a week, 365 days a year and on occasion will require work during week-ends and holidays. REQUIREMENTS: ? High School diploma or equivalent required. ? 6+ months industry related experience. ? Complete confined space entry (CSE) and 40 Hour OSHA Training. ? No serious moving violations in past 3 years, i.e., Reckless driving, Driving to endanger, Open alcohol containers, etc. ? Clean driving record, for the purposes of CHESI, includes: No more than 2 moving violations in the past 3 years; No DUI/DWI in past 3 years; No preventable accidents in the past year; No more than 2 preventable accidents in the last 3 years. ? Valid drivers license required as a continuing condition of employment ? Knowledge of RCRA requirements/regulations. ? Knowledge of Department of Transportation (DOT) regulations. Environmental Protection Agency (EPA) waste codes, manifesting and Land Disposal Restrictions (LDR) preferred. ? Knowledge of chemicals. ? Able to travel, work weekends, will wear a pager. ? Able to take and comply with directions and perform multiple tasks. PHYSICAL REQUIREMENTS: ? Position involves strenuous physical exertion. ? Available for 24/day on-call basis. ? Requires standing, lifting up to 50lbs. ? Requires pulling/pushing, carrying, grasping, reaching, crawling, stooping and crouching in confined spaces; Requires walking, climbing, speaking, listening, color determination and clarity of vision at 2 feet or more (with or without lenses); Requires sitting. ? Requires the ability to properly wear and use personal respirator equipment and other forms of personal protective equipment (PPE) including levels A,B,C,D & E, including full encapsulation PPE suits which can elevate body temperature substantially during strenuous exertion. Employment is contingent upon a successful background check and drug screen. Some positions also require a pre-hire medical exam. Must meet all work eligibility requirements. Environmentally-responsible business. We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class....

EHS Coordinator

Establish and Manage safety andenvironmental programs. Schedule and conduct safety and environmentalorientations for newly hired employees, periodic refresher training andscheduled safety meetings. Identifies hazardous workplace conditions, removes hazard and/or protects employees by guarding, revising work procedures, and training or requiring use of protective clothing and personal protective equipment. Develop, implement and manage PSM and RMP programs in the plant. Takes effective steps to ensure that workplace conditions comply with applicable federal, state, and local occupational safety and health standard provisions of any labor agreement, ensuring that all required records are prepared and maintained. Participate in Occupational Safety and Health Administration (OSHA) inspections and in any procedures and may follow. Leads, plans, and organizes behavior based safety process and database. Reviews all data with core BHP leadership team and proposes new PIP (Performance Improvement Plans) as appropriate based on data. Investigates, prepares, and forwards as required reports on near miss, injuries, and fatalities. Conducts and coordinates on safety training with all current and new employees. Communicating safety/environmental issues to department managers and employees Assists in planning for changes in physical facilities to meet new and current environmental requirements. Writes and updates environmental and spill-control manuals and procedures. Prepares environmental impact statements and applies for all new permits and renewals as appropriate. Train employees and ship hazardous materials per DOT/IATA requirements Develop and implement safety programs and policies throughout the production facility. Oversee the permitting process to comply with OSHA and EPA. Spearhead facility compliance with state, federal and local EH&S laws, regulations and standards. Interface with Federal, State and Local regulatory personnel regarding issues associated with reporting, permits, compliance audits and safety program development. Work with Federal, State and Local regulatory authorities to assure plant compliance with environmental regulations and standards. Spearhead the development of EH&S-related goals, targets and other objectives for the plant (AWAIR) Develop programs and procedures to assure that stated goals and objectives are achieved. Lead compliance audits, and supervise drills and other emergency related events. Internal Contacts: Monthly Interactions with employees at all level of the company to educate and train on the GEVO EH&S policies and procedures Weekly interactions on processes, MSDS, chemical and Biological safety procedures and R&D MOC process External Contacts: Contractors involved in site project which would involve Local authorities including waste water district, fire department, etc. Waste disposal companies and EH&S supply companies...

Senior Software Engineer

As a global provider of IT staffing services and the second largest in North America, Modis connects the very best IT professionals to great opportunities at leading companies. And we do it every single day - for both temporary and permanent assignments and across virtually all industries. We use our insight, flexibility and expanded resources to anticipate the needs of leading tech companies and help them make exceptional connections with top tech talent. We currently have a career opportunity for a Senior Software Engineer in San Diego California. Description We are looking for an experienced software developer that is a highly innovative, results-driven individual to support a revolutionary platform for genetic analysis. This assay requires custom data acquisition, multi-disciplinary integration, novel analyses, and inspiring visualizations that will provide insight into structural variation and its relationship to disease. This is a unique opportunity and a demanding position suited for an individual who wants to make an impact and is motivated to learn. This position requires a large range of skills and abilities to provide solutions that spans instrument control, data analysis, and user interface. Our goal is to produce high quality commercial products that enable our customers to significantly expand their understanding of the genome. The successful candidate will have an interest to learn or a demonstrated ability to build high quality, engaging applications that simplify, communicate, and enable the user to control, visualize, and investigation genomic data. Applicants need to show experience in one or more of the following areas: software/hardware integration, algorithm integration, user interface design, and/or the manipulation of complex data. Additional skills that will make a candidate stand out include: human factors design, expertise with industry standard genomic analysis tools, bioinformatics experience, agile methods, cluster computing, and workflow concepts. We are looking for an artist and an engineer that can summarize and organize complex data to convey biological meaning. The applicant should be motivated by the application of science to resolve complex and real-world problems through software. Responsibilities ? Help/lead the team to organize, design, develop, integrate, test, and deliver high quality applications to support instrument control, analysis, and visualization tools. ? Collaboration with team leaders, project managers, bioinformatics, molecular biology and customers to ensure the software products are accurate, effective, and easy to use ? Collaborate with internal and external customers to refine, improve, and expand our data processing pipeline ? Learn and continue to broaden your skill set of the technologies to deliver exciting, effective and innovative solutions. Qualifications ? Languages: C#, C++, Python, .NET or similar ? Technologies: WPF, MVC, MVVM, HTML, JavaScript, cluster compute, Cloud, and scripting ? Operating Systems: Windows and Linux ? Education: Bachelor?s/Master?s Degree in math, computer science, engineering, or other relevant discipline ? Experience: 5 years+ of software development for complex scientific tools ? Applications: Commercial instrument control, desktop applications, and/or web application development ? Work Habits: Very strong analytical, communication, group interaction, and interpersonal skills ? Strategies: Code organization, Agile concepts, Customer Driven Development, Test Driven development, SW project life cycle Local candidates will be given strong preference Please send resumes (Email Address Withheld by Request)...

Environmental Consultant / Assessor

Environmental Consultant / Assessor ODIC Environmental , a provider of environmental consulting services for the private, public and financial sectors, is seeking an entry to mid-level Environmental Assessor to join our operations in the Southern California region. The ideal candidate will have 0-3 years experience pertaining to Environmental Site Assessments projects. Responsibilities: Conduct Environmental Site Assessment projects in accordance with ASTM Standards and local, state and federal regulations Perform field inspections Technical report authoring Data compilation and organization...

Imaging Engineer

Job Title: Imaging Engineer Location: Raritan, NJ Duration: 12+ Months with possibility of extension Responsibilities: The candidate will have primary responsibilities to develop algorithms for processing multispectral images and performing object identification and feature extraction from biological samples. Specific responsibilities will include: Develop computer vision and image understanding algorithms that enable automated interpretation and information extraction from images Conduct cutting-edge research that leads to real-world commercial applications and translate innovative ideas and algorithms to prototype software and solutions Develop innovative solutions and implement prototypes, employing an ?experiment and learn" approach to design experiments that assess feasibility In support of these, the individual is expected to: Conceive, plan, and implement solutions to technical problems requiring unconventional approaches, new designs and equipment and/or process development. Serve as the company imaging specialist; keep abreast of new technical developments affecting the organization in the area and image processing and analysis Interact with software developers during implementation of imaging algorithms in the commercial product Practice company safety and quality policies and procedures Ensure personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance. Note: Interested candidate can send resume at or can call on 973-646-9983 ....

Product Development Design Engineer

Company Profile Oceaneering is a global oilfield provider of engineered services and products primarily to the offshore oil and gas industry, with a focus on deepwater applications. Through the use of its applied technology expertise, Oceaneering also serves the defense, entertainment, and aerospace industries. Oceaneering?s business offerings include remotely operated vehicles, built-to-order specialty subsea hardware, deepwater intervention and manned diving services, non-destructive testing and inspection, and engineering and project management. Oceaneering Space Systems (OSS) is a precision engineering and manufacturing group which specializes in turn-key design, development, manufacturing, certification, maintenance, and testing of extra-vehicular and intra-vehicular (EVA & IVA) tools and equipment for astronauts, including the Constellation Space Suit System; life support and environmental control systems for space; robotic systems for military, space, and biological research; and thermal protection systems for launch vehicles. We also provide specialized engineering and support services in these areas, and astronaut training in NASA?s Neutral Buoyancy Laboratory and Space Vehicle Mockup Facility. For more information please go to www.oceaneering.com and click on Advanced Technologies, then click on Space Systems. Position Summary OSS is currently looking for talented and experienced engineers to support the development of new and enhanced products for both the aerospace and oil and gas industries. The Product Development Engineer is responsible for product concepts and the subsequent design, manufacturing, and testing of the product. Responsibilities include the forecasting, planning, and coordination of the design, manufacturing, certification, and integration efforts. Areas of accountability include the overall pace of development, product quality, customer communication, and the product costs. This position may also involve sustaining engineering and real-time NASA mission support. Duties & Responsibilities Uses appropriate engineering techniques and judgment, based on experience, to work complex problems requiring in depth analysis and evaluation. Has knowledge and hands on experience with design and risk mitigation methodology for their area of expertise. Determines the design concept and/or system approach based on the thorough evaluation of detailed requirements and/or general performance specifications. Defines or determines which technologies are applicable. Defines test and product requirements and conducts negotiations as necessary to obtain full agreement for these requirements by all concerned. Prepares and coordinates formal design approval documentation and coordinates design approval with Senior Engineer....

Sales Manager - Waste Water Treatment Systems (Oil & Gas focus)

Our client specializes in the design, manufacture and complete delivery of ?ready for use" industrial waste water treatment and waste-to-value projects. Our client is active worldwide and has 2400 references in more than 50 countries with focus on the Food, Beverage, Dairy, Textile, Pharma, Oil, Gas and Agricultural industries.To further upgrade and expand their global team of professionals, we are currently seeking to fill the vacancy of Sales Manager Oil & Gas to join and grow the client?s North American business unit. Job Description: We are looking for a high achiever who will be responsible for new business development while also providing a high level of sales and service to existing accounts across the USA with a focus on the Oil & Gas industry. The job requires an individual with experience in selling complex wastewater treatment systems in a Business-to-Business environment. This is a great position for sales professionals with a can-do-attitude who are able to thrive in a very independent and self-starting setting. Key elements are: Realizing and exceeding budgeted revenue and margin expectations; New business development / Sales of large and complex systems; Up-selling en cross-selling existing accounts; Customer visits; Detailed fact finding and questioning on application and technical properties; Keeping track of market developments and informing customers about important developments; Working in an international environment. Job Highlights: Direct sales and customer relationship Fast growing Global organization Base location: Work-from-home office with extensive travel to customer locations Target Market: Conventional and unconventional Oil & Gas, both upstream and downstream Attending international sales & marketing meetings multiple times a year in Europe Directly reports to the Director North America Salary range: $80,000 - $100,000 plus commission...

Cleaning Validation Engineer

This leadership position is responsible for managing the cleaning validation and verification program for SAFC, a manufacturer of potent and non-potent pharmaceutical products. This position requires an understanding of the requirements for the removal of product and product-related residues from manufacturing equipment to acceptable levels, and the analytical methods used to detect them. Analysis includes the use of HPLC, UPLC, TOC, and LCMS. This position demonstrates the ability to work on, and solve, problems independently with minimal guidance; has the responsibility for working with Process Development and Manufacturing departments to ensure safe removal of product residues; develop methods to detect low level product residues and validate or qualify methods appropriately. This position assists to maintain project timing /costs by interacting with internal and external customers to assure project goals are met. This position is responsible for guiding the work of analysts supporting the cleaning program to assure production schedules are maintained; reviews and verifies the accuracy and quality of analysts' test results and reports; and works closely with Quality Assurance and Management to drive improvements and ensure a high level of quality. ? Excellent understanding of chromatographic techniques, especially LCMS ? Develop testing methods to support cleaning verification program via LCMS, HPLC, UPLC and/or TOC; validate or verify methods as necessary. ? Possesses a good understanding of cleaning requirements necessary to support a regulated environment. ? Exercises independent judgment in developing methods, techniques, and evaluating criteria for obtaining results. Works on complex and challenging problems in which analysis of data requires an in-depth evaluation of various factors. Applies theoretical concepts and good scientific rationale to identify root cause of issues and implement corrective and preventive actions. ? Assumes a leadership role within the department. ? Able to solve problems and make decisions while ensuring management is appropriately informed. ? Provide guidance and oversees new and less experienced personnel; provides training to new and less experienced personnel in SOP content, analytical techniques, and instrument use pertaining to cleaning validation program; reviews analytical data for accuracy and quality. ? Coordinates with internal and external customers to maintain project timelines while keeping management informed. ? Writes and revises technical documents and reports ? Works in compliance with effective procedures and regulatory requirements outlined in ICH Q7 and 21 CFR Parts 11, 210 and 211 as applicable. Possesses an understanding of FDA /ICH guidelines....

Engineering Development Program (EDP)

Job Description Job Title: Engineering Development Program (EDP) Job ID: 119015 Location: USA-North Carolina-Charlotte Full/Part Time: Full-Time Regular/Temporary: Regular Return to Previous Page About SPX Corporation Based in Charlotte, North Carolina, SPX is a global, multi-industry manufacturing leader with over $5 billion in annual revenue, operations in more than 35 countries and over 15,000 employees. The company's highly-specialized, engineered products and innovative technologies are helping to meet rising global demand for electricity and processed foods and beverages, particularly in emerging markets. Job Summary The SPX Engineering Development Program (EDP) is created around the principle of hiring the best and most talented people, and then providing the necessary means for them to constantly learn, be challenged, mentored, and successful. The EDP is the premier entry point in SPX for either product design engineers or manufacturing engineers who have recently earned a Bachelor?s Degree in Electrical Engineering, Industrial Engineering, Manufacturing, Mechanical Engineering, Civil/Structural Engineering, Agricultural/Biological Engineering, or other related engineering disciplines, or their Masters Degree in Engineering. Current EDP needs may vary depending upon business needs. During the course of a two-year development program, the engineer will be given four distinct developmental assignments. The EDP begins in June of each year and positions are available in numerous locations throughout SPX. KEY EXPOSURES TO ENGINEERING EXECUTIVES AND BUSINESS UNIT OPERATIONAL LEADERS: The EDP rotations provide significant exposure to the company?s officers and senior management team, including the Corporate and Business Unit engineers. These rotations will provide a ?big picture? view of the corporation while at the same time offering hands on, real experiences that aim to sharpen your engineering skills in multiple technical areas. ENGINEERING ROTATIONS MAY INCLUDE: ? Lean Manufacturing ? Supply Chain ? Quality Engineering ? Line / Cell Supervision ? Process Engineering ? Production and Inventory ? Project Management / Engineering ? Product Development ? Product Design ? Applications Engineering ? Product Management / Marketing OBJECTIVES OF ENGINEERING ROTATIONS: The EDP rotations and developmental assignments will be established to help ensure that each participating engineer is: ? Given significant and increasingly challenging professional assignments as the rotation progresses ? Provided distinct work assignments with specific, measurable goals outlined in a detailed rotation plan ? Professionally prepared to add value in their designated assignment at program?s completion ? Able to fully embrace the organization?s culture and environment ? Assigned a mentor at the beginning of their assignments who will be responsible for assisting in their development during the program ? Provided regular intervals of formal and informal feedback throughout each assignment to ensure continued growth THE ROTATIONAL PROGRAM FOCUSES ON THE DEVELOPMENT OF A CORE SET OF COMPETENCIES: ? Leadership/Influencing ? Self-motivation ? Teamwork/Business Partnering ? Judgment/Problem-solving ? Innovation/Business Maturity ? Communication ? Cross-functional Learning Qualifications ? A Bachelor?s Degree in Engineering with a GPA of 3.0 or higher ? Relevant internship / co-op experience (professional experience in manufacturing is desired) ? Adaptable, flexible and able to work in changing work environments ? Willingness to travel to or potentially reside in different geographic locations during the program ? Strong analytical and communication skills, technical knowledge, mathematical skills, and problem-solving skills ? Ability to work in a team-oriented environment that is fast-paced and challenging ? Self-directed, excellent initiative, strong organizational and communication skills ? Exhibit strong ability to handle multiple demands with a sense of urgency, and willingness to learn How To Apply If you are open to pursuing this time sensitive opportunity, please complete an application online by clicking 'APPLY NOW.' To begin your application, we recommend that you either copy and paste your resume or upload your resume. This process takes approximately 5 minutes to complete. If you do not have a resume to upload, you may build a resume online; this option may take up to 20 minutes to complete. Thank you for your interest in our company. Return to Previous Page...

Quality Engineer I

*****Important information: This position is recruited by a remote Kelly office, not your local Kelly branch. Please submit your resume to be considered for this position by pressing the ?SUBMIT RESUME? button below or you can send your most up-to-date resume to . If you have questions about the position, you may contact me, the recruiter recruiting for this position at or call at 214-766-2593****** Job Title: Quality Associate I Client: Baxter Position Type: Temporary or Contract Type of Hours: Full Time Contract Length: 3 month or Longer Pay Rate: $24.50/hr JOB DESCRIPTION: JOB DUTIES: Conduct and write CAPA investigations to determine the root/probable causes for nonconformities/out-of-specification events/complaints Must conduct defect/failure analysis on product as required Ensure business needs and timeliness requirements are met or exceeded Recognized by various levels of the facility as a CAPA owner expert in their area and be able to demonstrate leadership ability. Implements the quality systems procedures and manages compliance in a section or department. Understands and assures conformance to regulations in a section or department. Interfaces with regulators during regulatory inspections Identifies and manages continuous improvement projects with the objective of achieving quality, reliability and cost improvements. Strong management skills and the ability to interact with all levels of plant personnel are required Thorough knowledge of applicable CAPA procedures, specifications, regulations and standards Must implement company policies and assure conformance to specifications and plant procedures Capable of making independent decisions regarding product conformance and handle deviations as they arise. Must inter-face with other plant functions Must have knowledge of both plant and department environmental health and safety regulations and comply with said regulations accordingly Candidates must meet visual acuity requirements as documented in Baxter Cleveland Human Resources Procedure 1.04 Must perform all other duties as assigned by the supervisor QUALIFICATIONS: B.S. Degree in the Biological Sciences or Engineering field preferred Exceptional organizational and technical problem-solving skills. Ability to manage multiple projects. Requires strong written and oral communication skills. Good project management skills. Working knowledge of FDA regulations and application of Good Manufacturing Practices. *****Important information: This position is recruited by a remote Kelly office, not your local Kelly branch. Please submit your resume to be considered for this position by pressing the "SUBMIT RESUME" button below or you can send your most up-to-date resume to . If you have questions about the position, you may contact me, the recruiter recruiting for this position at or call at 214-766-2593****** About Kelly Services ® Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions. Kelly ® offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis. Serving clients around the globe, Kelly provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter . Download WorkWire ? , a free career and employment resource iPad® app by Kelly Services. iPad is a trademark of Apple Inc., registered in the U.S. and other countries. App Store is a service mark of Apple Inc. Since employing its first engineer in 1965, the Kelly engineering specialty has grown to be recognized as a leading provider of engineering resources to customers in such industries as automotive, chemical, defense, electronics, energy, medical device and pharmaceutical. Want more information? Visit kellyservices.com/engineering Connect with us on...

Engineer Systems Architect 3 (ECS/PP)

ECS/PP engineer to support E-2D PIOC trade study project. Under direction within the ECS/PP/Hydraulics/Fire Protection group, individual will assist in the analysis and development of cooling subsystems requirements. Duties are as follows: Within parameters established for design specifications interface with related technologies and other Air Vehicle engineering disciplines to prepare and develop cooling design recommendations. Participate in trade-off studies of forced air distribution system designs and solution to potential or actual design and fabrication problems, providing necessary data on assigned aspects of specific studies. With supervisory or lead personnel, participate in negotiations with supplier to establish criteria for the design, development, test and fabrication of components and systems. Participate in design reviews and coordinate resultant changes in forced air distribution system and other E-2D subsystems with Procurement, Manufacturing and subcontracts to assure scheduled completion of designs and end product. Coordinate detailed tasks assigned to junior engineering personnel. Engineer is expected to have design experience with pneumatic (high/low pressure), bleed air systems, fuel and propellant, fire supression and detection, lubrication, auxiliary power, induction/exhaust, engine starting, power transmission, cabin and equipment environmental control, life support, oxygen, ice protection, defogging/defrosting, windshield clearing, avionic thermal conditioning, liquid cooling, and chemical/biological systems. This position may begin in Bethpage, NY but will be permanently located in Melbourne, FL....

Sr. Public Health Specialist

The Port Authority of New York and New Jersey is a bi-state public agency operating some of the busiest and most important transportation links in the New York / New Jersey region including The Port Authority Trans Hudson Corporation (PATH), the primary transit link between Manhattan and New Jersey communities and suburban commuter railroads. We currently have an opening for a SR. PUBLIC HEALTH SPECIALIST to work primarily at JFK and LaGuardia Airports in Queens, NY. Position will also require travel to the Port Authority Technical Center located in Jersey City, NJ. Under the direction of the Supervisor, Public Health, the selected candidate will provide expert technical and professional services related to evaluating and measuring Agency and tenant compliance associated with Public Health codes, policies, procedures, industry standards and New York City Department of Health, NY and NJ State and Food & Drug Administration (FDA) Federal regulations by: performing food establishment assessments and evaluations, evaluating tenant food establishment construction & alteration plans and submittals, implementing Public Health Programs, investigating foodborne illnesses and public health complaints, and responding to public health emergencies that arise within the Agency. The Public Health Specialist will be responsible for: Performing food establishment assessments and evaluations located on all Port Authority properties (including but not limited to JFKIA, LGA, and Stewart International Airport). Applying NYC Department of Health, NY and NJ state health codes, and the FDA Food Code, and industry practices, and procedures and preparing inspection reports explicitly noting each violation of the public health codes. Reviewing architectural drawings for the construction and renovation of all new and existing food establishments located on Port Authority property for compliance with NYC Department of Health, NY and NJ State and FDA health codes. Prepare reports noting noncompliance issues with public health codes. Conduct final construction inspections of each establishment to ensure that food establishments are constructed in compliance with public health codes and approved architectural drawings. Investigating alleged foodborne illnesses and outbreaks at food establishments and obtaining food samples as necessary following industry procedures and guidelines for laboratory analysis. Performing investigations that address potential exposure of employees, tenants and the public to a variety of public health, chemical and biological hazards. Implementing NYC, NY, NJ and Federal public health programs at various Port Authority facilities Responding to emergencies incidents and crises at all Port Authority facilities on a 24-7-365 basis and provide technical expertise in public and environmental health issues. Interacting with NYC Department of Health, NY, NJ and Federal Public Health representatives to discuss and address issues relating to the Port Authority. -...

Systems Engineer

Schafer Corporation is a scientific and engineering company providing solutions to mission critical challenges in national security, information technology, and communications. We offer a broad array of innovative products and services to address our customers' most complex technology-related needs. We provide integrated solutions that advance technology and improve operations. We understand our customer's challenges and work hard to deliver effective results. Schafer Corporation is seeking a Systems Engineer in support of The Domestic Nuclear Detection Office (DNDO). DNDO is a jointly staffed agency within the Department of Homeland Security. DNDO is the primary entity in the U.S. government for implementing domestic nuclear detection efforts for a managed and coordinated response to radiological and nuclear threats, as well as integration of federal nuclear forensics programs. Additionally, DNDO is charged with coordinating the development of the global nuclear detection and reporting architecture, with partners from federal, state, local, and international governments and the private sector. Location of work is Washington, D.C. . Responsibilities: Responsibilities will include but are not limited to: We are seeking individuals with strong engineering backgrounds to support homeland security research and development (R&D) programs. Engineers are required to support the following areas in support of DHS R&D efforts: Systems Development: The engineer role requires experience in direct execution of major efforts in translation of a system, program, or activity into a preliminary and detailed design, while performing risk analysis, identification, and mitigation in order to integrate various components to produce prototypes and models. In order to accomplish these tasks, the individual must be familiar with computer aided design, design studies and analysis, research and development, specification preparation, configuration management and document control, fabrication, assembly, and simulation and modeling. Testing and Evaluation: Participate in and the supervise testing and evaluation to validate performance of new or emerging technologies. This may include hands-on prototype development, environmental testing, independent verification and validation, as well as conducting physical tests of systems. Logistics Management: Provide support for project logistics. The Engineer will be required to supervise logistic personnel, prepare logistic plans, policies, and procedures. Ensure that the proper consideration is included in the system development for each major milestone, and conduct logistic and development reports. Logistics engineering staff must have experience in the design, programming, program design, and documentation preparation for complex systems. Also, the role requires support for system maintenance planning, and life-cycle supply requirements and processes to meet O&M needs. The Engineer role requires a strong background in systems development, functional and data requirement analysis. In addition, this role requires experience in concept studies, requirements definition and analysis, cost analysis, cost performance trade off analysis, feasibility analysis, regulatory compliance support, technology conceptual designs, and special studies and analyses. #cb4/29/2013...

Senior Intelligence Analyst

This position supports numerous efforts related to threat information analysis and intelligence support to various organizations within the National Capitol Area. This position will provide comprehensive intelligence support to various exercises and working groups (including Land Warfare, Air Warfare, Naval Warfare, Chemical/Biological Warfare, Space Warfare, and Information Operations Warfare). This position will provide frequent intelligence briefings and coordinate briefing topics. This position also reviews and provides expert input into critical T&E and intelligence documents including Initial Capabilities Documents, Capabilities Development Documents, Capabilities Production Documents, Test and Evaluation Master Plans, Test Plans, Capstone Threat Assessments, System Threat Assessments, and other relevant documents....

Quality Manager - Chemicals

Quality Manager - Chemicals Global leader in the development, production and distribution of a wide range of chemicals seeks a Corporate Quality Manager to define, establish and lead the company's quality systems and distribution program. The Corporate Quality Manager will: Lead QA strategies, implementing quality processes, guidelines and control plans in compliance with industry and company standards. Lead continuous improvement in critical areas of the quality program using improvement tools including SQC, 8D, Six Sigma, 5S and Value Stream Mapping. Develop KPI goals and supporting strategy in aligning improvement targets and organizational objectives. Lead cross functional teams engaged in identifying and resolving quality issues impacting raw material and product quality, ensuring customer satisfaction. Lead internal audits to ensure continuous improvement, facilitate external audits....

94F Special Electronic Devices Repairer

The Army National Guard relies on electronic devices in areas ranging from weather forecasting to combat. As a Special Electronic Devices Repairer, you will ensure that night vision equipment; electronic distance and azimuth-orienting devices; battlefield illumination devices; nuclear, biological, and chemical warning and measuring devices, as well as other vital instruments and tools are meticulously maintained and operational. Specific duties of the Special Electronic Devices Repairer include testing instruments, navigational controls, and simulators; reading technical diagrams and manuals; replacing parts; ensuring quality control measures; and troubleshooting and inspecting equipment. Also, advanced level Special Electronic Devices Repairers are expected to supervise and train other Soldiers in the craft. Plus, this job track can help you achieve a rewarding civilian career. The skills you learn as a Special Electronic Devices Repairer will prepare you for positions with manufacturing companies, medical research facilities, satellite communications, or commercial airlines. Also, this could be a step toward a job with the federal government, as well as possible certification as an Associate Certified Electronics Technician. Earn while you learn Get paid to learn! As an Army National Guard Special Electronic Devices Repairer, you will learn valuable job skills while earning a regular paycheck and qualifying for tuition assistance. Job training for a Special Electronic Devices Repairer requires 10 weeks of Basic Training, where you learn basic Soldiering skills. Advanced Individual Training consists of 23 weeks of training. Training is spent in a classroom, practicing on equipment, and in the field under simulated combat conditions. Applicants must meet minimum qualifications. Actual MOS assignment may depend on MOS availability. Benefits subject to change....

ELECTRONIC TECHNICIAN

Responsibilities/Duties : -Responsible for the assembly of electronic equipment. -May disassemble, modify, rework, reassemble and test assemblies and subassemblies using hand tools and power tools to assemble units according to product specifications. -Requires a high school diploma or its equivalent. -May be required to complete an apprenticeship and/or formal training in area of specialty. -May require 2-4 years of experience in the field or in a related area. -Has knowledge of commonly-used concepts, practices, and procedures within a particular field. -Relies on instructions and pre-established guidelines to perform the functions of the job. -Works under direct supervision. -Special Considerations: Lifting is generally in the 10 to 15 Lbs. range with minimal repetitions. -Exposure to machinery, chemical, biological, and physical risks is minimal. -Soldering skills preferred: Additional tools used will be tweezer, vacuum wands and tork drivers. -Understanding and awareness of chemicals in the work area. This position requires ESD (Electro Static Discharge) certification and this will be managed by Honeywell on the first date of orientation for employee. This is no longer a requirement during prescreening by suppliers. Training will be (In class room) 1st day 8:00 AM. Additional training might be required on the first shift. Work Schedule: - 2nd shift 3:30PM to 12:00 AM Mon-Fri overtime when needed may be before or after shift and possibly on Saturdays CANDIDATES MUST BE A U.S. CITIZEN ONLY...

Principal Engineer 1

Principal Engineer 1 (SED-2014-118) Position Qualifications: Responsibilities: Design, program, install, and validate process control/industrial equipment and systems. Research, design, provide cost estimates, review design specifications, provide oversight of installation and factory acceptance testing of specified test systems. Write and supervise, test events and analysis events and write post-test reports. Demonstrate insight into industry best practices Requirements: Demonstrated ability to work under pressure in a team environment. Strong knowledge of current networking and computer technology. Secret security clearance; TS/SCI preferred. Education: Bachelor Degree in an Engineering discipline...

Quality Engineer-US - NJ - Raritan

Ortho Clinical Diagnostics, Inc is recruiting for a Quality Engineer, located in Raritan, NJ. Ortho Clinical Diagnostics, Inc. (OCD) is a leading provider of in vitro diagnostic products and services, offering accurate, timely, and cost-effective solutions for screening, diagnosing, monitoring and confirming diseases. The company has approximately 3,800 employees around the world serving the global clinical laboratory and transfusion medicine community, and is committed to providing customers with products, services and process solutions to make labs more efficient in delivering the quality test results doctors and patients need. OCD was recently acquired by global alternative asset manager The Carlyle Group as an independent, freestanding company. With new leadership and accelerated investment in research and development, OCD is well positioned for growth as a leading player in the global diagnostics market, tapping into rising demand for sophisticated medical diagnostic products and services worldwide The Quality Engineer will provide leadership and technical support to Quality & Regulatory Compliance (QRC) and Operations staff on select aspects of the biological manufacturing process controls. Utilize key Quality Engineering (QE) principles, tools, and practices to optimize systems and processes that are aligned with the overall business and the Quality Policy. Support manufacturing in addressing quality events related to product release including non-conformance, product disposition, root cause investigation, laboratory OOS, and corrective/preventative action. Assure inspection readiness programs are effectively implemented within the organization. Provide comprehensive product team support for quality system design and audit, compliance assessment, and for support of steady state manufacturing processes. Drive quality related decisions, with appropriate approval authority (both data-based and risk-assessment-based decisions). Utilize industry and process excellence standards on a moderately complex level in daily quality operations, including good manufacturing practices (GMP), equipment engineering system (EES), and international organization for standardization (ISO). This individual will require a strong background in validation, statistical process controls, and regulatory compliance. Responsible for addressing or escalating product and process complaints, and implementing quality assurance programs in the medical device, biologics and parenterals for Transfusion Medicine. Support equipment and process validation by participating in the development of studies and validation protocols to assess manufacturing capability/reliability. Demonstrate working knowledge of current and applicable GMP regulations e.g.: ISO13485 / 21 CFR Part 820. Demonstrate and utilize knowledge of manufacturing process and detailed knowledge of own work area. Demonstrate knowledge of and ability to implement the CAPA process as per SOPs. Actively supports CAPA to drive improvements. A minimum of a Bachelor's degree in Chemistry, Biochemistry, Biology, Chemical Engineering and/or related discipline is required. A minimum of 2-4 years experience in Quality, Regulatory and/or Compliance in a highly regulated manufacturing environment (Diagnostics, Medical Device, Pharmaceutical, or Consumer) is required. Knowledge of current and applicable GMP regulations is required. Knowledge of Quality System Regulations (QSR) and International Organization for Standardization (ISO) regulations required. Ability to make risk based decisions that will effectively support the business and company policies. The ability to effectively prioritize and manage multiple project workloads is required. Candidates who possess experience with statistical tools such as SPC, Sampling Plans, Experimental Design and Optimization tools are preferred. Microsoft Office tools experience for communications, reporting and data analysis is required (Word, Excel, PowerPoint, etc.). Report writing skills will be required. This position will require up to 10% travel and will be based in Raritan, NJ. Ortho-Clinical Diagnostics, Inc. is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law. *QUA...

Environmental Compliance Inspector / QSP

ETIC in Costa Mesa is seeking a Compliance Inspector who is a Qualified SWPPP Practitioner (QSP). The candidate will help manage construction support activities that include, but are not limited to, preparing and implementing Storm Water Pollution Prevention Plans, dewatering plans and permits, and preparing spill prevention and hazardous material management plans. Essential Duties and Responsibilities: Manage all environmental aspects associated with field construction projects, including storm water compliance, BMP installation, dewatering, hydro-seeding, and field water treatment, etc.; Conduct inspections on a variety of construction sites as specified in the SWPPP; Plan, organize and administer the permitting, inspection, monitoring and data management of storm water construction projects, in accordance with federal, state and local laws; Provide technical expertise for storm water services for clients; Assist in various environmental compliance tasks and reporting, including SWPPP writing; Coordinate SWPPP development and implementation in alignment with biological and/or areas of environment concerns and limitations; and Additional project related duties as required....

Engineer / Science

Engineer / Science About the Company: Global Engineering & Technology (GET) and Nuclear Safety Associates, Inc. (NSA) have combined our common corporate values and core competencies by establishing a formidable 8(a) Joint-Venture business entity (GET-NSA, LLC). As the recent awardee of the Department of Energy (DOE) Oak Ridge Operations Information Technology Support Services contract and the DOE Office of Health, Safety, and Security Office of Classification Specialized Technical and Administrative Support Services contracts, GET NSA is well positioned to become a premier provider of technical and engineering support services to our clients. GET-NSA, LLC , a Federal Government Small Business Firm with locations nationwide, is currently searching for recent engineer and/or science degree college graduates only to provide support to their Document Review Team in support the Department of Energy's National Declassification Center, National Archives and Records Administration (NARA) in College Park, MD. Duties will include Conducting classification reviews of government agency 25-year-old or older documents of Permanent Historical Value in accordance with applicable laws, regulations, DOE orders, and DOE Office of Classification procedures for RD, FRD, NSI, and UCNI. The technically specific areas include: Nuclear weapons design, development, testing, production, and deployment Special nuclear material (SNM) production technologies Nuclear weapons safeguards and security, and transportation Intelligence/counterintelligence Chemical and biological defense activities Radiological weapons Space nuclear reactors and naval nuclear propulsion Based on provided training and formal classification guidance, the individual determines whether information is classified or unclassified but sensitive. Based on initial training and experience in the Document Reviewer Level 1 position, the individual is expected to progress to Document Reviewer Levels 2 and 3, which afford greater responsibilities. Primary work location is the DOE facility in the National Declassification Center (NDC), National Archives and Records Administration (NARA), College Park, Maryland. Given the sensitive nature of the work, applicants must be a US Citizen and MUST be able to qualify for a DOE Q or TS clearance, based on a Single Source Background Investigation....

Water / Wastewater Operator in Training - ts8450

Water / Wastewater Operator in Training - ts8450 Pay Rate $15 - $16/hr 3 month contract to possible hire Santa Fe NM 87508 Candidate chosen must pass a MVR check Responsibilities: Performs a variety of tasks in the operation and maintenance of a water/wastewater treatment plant on an assigned shift. This position typically holds or is working on first level water/wastewater treatment certification. Essential Duties and Responsibilities ? Learns and gains skills involving the maintenance of equipment and servicing work in the plant ? Operates treatment facilities to control flow and processing of water/wastewater, sludge, and effluent ? Operates valves and gates either manually or by remote control, starts and stops pumps, engines and generators to control and adjust flow and treatment processes ? Monitors gauges, meters, and control panels ? Observes and reports abnormalities to supervisor ? Maintains shift log and records meter and gauge readings ? Collects samples and performs routine laboratory tests and analyses ? Performs routine maintenance functions and custodial duties ? Understands and carries out oral and written directions ? Establishes and maintains cooperative relationships with those contacted during the course of work ? Performs other duties as required...

Quality Supervisor

Summary: To ensure the cost effective production of safe, quality products through the development and implementation of Food safety and Quality programs. Provide leadership, direction and training to technicians and operations personnel, including production supervisors, in matters relating to product quality and food safety. Position is responsible for the integration and coordination of Food Safety and Quality systems to ensure compliance with Unilever and Regulatory standards. Support WCM implementation through the Quality Pillar, FI technical support and team skill development. Position actively participates on RVS and GQE initiatives and serves as technical liaison with R&D for plant commercialization and VIP projects. Responsibilities: Develop and implement food safety and quality management systems and corresponding programs that comply with Unilever, FSSC 22000, GFSI and regulatory requirements. Supervise laboratory technicians to ensure proper coordination with production planning and effective implementation of quality programs. Utilize WCM methods to develop and train laboratory technicians and plant teams in preventive oriented quality programs to promote the cost-effective production of safe, quality product within a continuous improvement setting. Responsible for WCM Quality Loss Tree and leading loss reduction actions. Supervise the review, monitoring and appropriate action regarding production processes to ensure conformance with critical factors, specification and plant and regulatory policies. Review and report on summary production data and improvement recommendations to PLT, RVS, R&D & Category Quality as it relates to food safety, quality and efficiency. Emphasize SPC as analytical tool and WCM as Continuous improvement tool. Supervise the sensory evaluation of in-process materials and finished products and make the necessary formula modifications as required to maintain or improve product attributes as a consequence of ingredient or process variations. Perform and document periodic sanitation and safety audits and make recommendations to management for improvement. Coordinates plant process capability assessment & commercialization for VIP& Innovation projects. Work with R&D to develop formulation methods that ensure the production of consistent quality products. Review new and revised product formulae to ensure that they conform to quality standards and are capable of meeting design specifications. Lead/(Participate on) loss elimination Focused Improvement with R&D, Engineering and Production supervisors utilizing SPC, WCM or other appropriate problem solving methods. Active participant on RVS, GQE, Category Quality cross functional initiatives. Assist Recall Coordinator on planning, directing, and coordination of the recall matters. Lab technicians receive direction from Quality supervisor, who also serves as back up for Q Manager. Support manufacturing VIP projects (capability testing / implementation), product hold investigations/ resolution /disposition. Assist in the development, review, standardization and alignment of internal plant / corporate policies and quality programs including SOP?s, HACCP, GMP and QVS. Utilize WCM methodology to integrate quality programs into the site WoW for all plant personnel....

Engineer 2

. Superior Group is looking for an Engineer 2 for our Client located in Walpole, MA This Manufacturing Engineer will provide incremental Manufacturing Engineering support while transfers from a legacy Material Resource Planning application (BPCS) to a new system (SAP). This will involve updating Manufacturing routers and Bills Of Materials, executing Engineering Changes and backfilling for other engineers as they support this major effort for a large biological product manufacturing site. It will also include participating in steps to ensure successful transfer of data. This manufacturing Engineer will have demonstrated experience creating Manufacturing procedures within a Regulated Industry. The candidate must have experience creating Bills Of Materials and Routers as well as experience working hands on in a Manufacturing environment. Experience with database application is desirable, as is experience with using Material Resource Planning application- SAP. The successful candidate will be results oriented and comfortable working in a fast-paced work environment. This candidate needs to be comfortable working within Teams and as an independent contributor....

Quality Engineer

The Quality Engineer supports the validations of a designated business unit, including the planning, writing and data analysis for validations. The QE uses technical writing skills,statistics and other tools to implement products and processes to supportproduction and laboratories. Responsibilities: Plan validation scope for product and process launches. Write protocols and reports demonstrating solid technical writing where background of projects and procedures are clearly presented and conclusions are definitively and clearly stated. Perform data analysis that includes use of statistical tools, trending, ability to perform correlation analysis and other calculations as required. Perform risk assessments independently and as a team applying techniques including FMEA and ALARP. Coordinate with internal and external personnel for standards, data, testing, or other activities, as needed. Perform other duties as assigned....

Packaging Engineer

Packaging Engineer Fareva is currently seeking an experienced Packaging Engineer to join their team in Richmond, VA. About Us Since the company was founded 20 years ago, our objective at Fareva has always been to offer customers impeccable service by providing tailored R&D, production and packaging facilities which fully satisfy their needs. Job Description With considerable knowledge in a specific field, the incumbent is responsible for tasks and projects related to qualification of alternate components, and component design. Work may include projects and tasks in any or all of the following stages: scope definition, feasibility, design/modeling, simulation, cost/benefit analyses, specification development, project planning, implementation, and post-implementation monitoring and follow-up. Developing detailed plans, the incumbent will contribute on cross-functional projects and may lead some focused teams, with involvement and coaching from their supervisor. Projects must achieve business, quality, and compliance objectives, and must be executed in a manner that assures full compliance with government regulations and internal company standards and values Job Responsibilities: Identify opportunities and contribute to the development of solutions for quality,efficiency, profitability, customer service, or compliance improvements. Apply new technologies or techniques to existing processes to ensure that legacy packaging processes benefit from advances in technology Process upgrades to incorporate new regulatory requirements, and process changes as required to utilize new components or materials. Help to define scope of project in consultation with supervisor and stakeholders. Individually or collaboratively through influence on a project team, define alternative solutions, and decision criteria used to evaluate the alternatives. Develop tactical plans and prioritize the routine tasks collaboratively with others to achieve project goals. Transition with project to contribute to key aspects of implementation efforts. Designs and specifies components that support product maintenance and launch Defines process, material, and product specifications for both control and response variables Evaluate alternatives or proposed changes through hypothesis testing, simulation, laboratory testing or other means Make recommendations on alternative selection. Develops detailed plans and prioritizes the routine tasks within the plan to achieve goals of incumbent?s projects Lead implementation efforts with complete responsibility for smaller-scope projects or for discrete portions of large projects With coaching from supervisor, may concurrently apply a technology across more than one project or work cell Identifies, resolves, and removes logistical or technical limitations and barriers to task completion, and elevates more systemic or significant issues to management if necessary Collaborate between sites where improvements have synergistic opportunities or where there are requirements for consistency or collaboration. Participates in focused, proactive problem-solving efforts for packaging component related issues Troubleshoots and resolves simple to moderately complex process issues, diagnosing technical problems and identifying short- and long-term solutions Works closely with cross-functional groups to resolve system problems to optimize output, and minimize cost Promotes cGMP compliance within the workplace by following site cGMP procedures Incorporate cGMP and regulatory compliance into all assigned projects scope, design and construction work....

Validation Engineer

Validation Scientist Engineer II Position Purpose: Designs, schedules, and executes scientifically sound qualification/validation experiments which demonstrate that manufacturing Equipment, Facilities, Utilities, Systems, and Processes are in compliance with regulatory requirements, product license restrictions, and industry guidance. Prepares detailed concise reports on completed studies that summarize test results and their conformance to the protocol acceptance criteria. Main Responsibilities and Accountabilities: 1 Responsible for achieving validation study objectives/schedules while working across multiple departments. Maintains close contact with appropriate functional groups (i.e. Manufacturing, Engineering, and QC Labs, etc.) to assure effective communication in regards to the needs and status of assigned validation studies 2 Prepares scientifically sound validation protocols that incorporate the defined specifications into acceptance criteria and assessment procedures. 3 Schedules and communicates validation study execution/testing with affected departments and personnel. 4 Collects, interprets, evaluates and communicates validation test data for conformance to validation acceptance criteria and/or to investigate and determine root cause for validation study discrepancies. 5 Prepares detailed, concise reports on completed studies that summarize the test results and their conformance to defined acceptance criteria 6 Researches governmental regulatory requirements and industry guidance on assigned projects to ensure that each study subject is challenged to meet, at least, the minimal required specifications. 7 Assists the department in developing programs and SOPs to meet current industry standards, site Quality, and external Regulatory requirements. 8 Provides technical support/training to Validation Technicians in areas of competency. Provides technical support other functional groups (i.e. Manufacturing, Engineering, and QC Labs, etc.) as needed. 9 Supports the facility in internal and external inspections. 10 Other tasks as required by Departmental Management. Position Qualifications and Experience Requirements:...

Regulatory Product Specialist

Regulatory Product Specialist We are always hiring, because Vascular Solutions is always growing. Successful both clinically and financially, we provide meaningful work, financial rewards and rapid growth opportunities for employees who want a chance to achieve based on their own merits. Please review the responsibilities and requirements of the position below. If you would like to join the nation?s fastest growing medical device company please begin the application process by completing the form at the bottom of the page and following the prompts to submit your resume to our Human Resources Department. As a Regulatory Product Specialist you will be responsible for: Preparing regulatory submissions and achieving market authorizations to meet project deadlines (submissions and authorizations include 510(k)s, pre-IDEs, PMAs, technical files/design dossiers, and other ROW applications) Ensuring regulatory requirements are met for labeling and promotional materials Maintaining regulatory file and communicating with regulatory agencies, as well as representing Regulatory on internal product development teams Reviewing and approving test protocols and reports (design verification, biocompatibility, sterilization, packaging, shelf-life, etc.)...

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