• Staff Quality Engineer

    Integra LifeSciences (Princeton, NJ)
    …of care. This position is for a Staff Quality Engineer, Global Supplier Process Validation with hands-on experience and proven success in Process Validation and ... be primarily engaged to ensure timely completion of process validation requirements of new products and life cycle change...ensure compliance with all appropriate regulations and standards, including FDA , ISO 13485, CMDR, MDR, 21 CFR Part 11… more
    Integra LifeSciences (04/08/25)
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  • Consultant

    Robert Half Technology (Warren, NJ)
    …flow cytometry techniques. + Applied understanding and knowledge of bioanalytical method validation guidelines governed by FDA or other global health ... authorities. + Demonstrated ability to work on complex problems to produce experimental data across one or more projects. + Demonstrated technical proficiency, scientific creativity, the ability to collaborate with others and the ability to think independently… more
    Robert Half Technology (04/24/25)
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  • Senior Quality Engineer I - Design & Reliability…

    Integra LifeSciences (Princeton, NJ)
    …Plan, Requirements Traceability Matrix, Clinical Evaluation Report (CER), Design and Verification/ Validation studies and Process Validation studies. + Coordinate ... development documentation such as product requirements, schematics, verification, and validation strategy/execution. + Coordinate, review and approve development documentation… more
    Integra LifeSciences (03/08/25)
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  • Associate Principal Scientist, Combination Product…

    Merck (Rahway, NJ)
    …and device product development, such as manufacturing process development and validation , design control, risk management, material and molding, design validation ... + Lead establishment of test methodologies, including method development and validation , internally or externally, per design verification strategy. + Lead strategy… more
    Merck (05/08/25)
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  • CQV Engineer Mid-Level

    Sokol Materials & Services (Skillman, NJ)
    …risk-based validation approaches. + Knowledge of regulatory requirements, including FDA , EMA, and ICH guidelines. Knowledge, Skills & Abilities: + Proficient in ... risk-based validation approaches. + Strong analytical, problem-solving, and communication skills. + Ability to work effectively in team settings and collaborate with… more
    Sokol Materials & Services (04/24/25)
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  • CQV Engineer Senior Level

    Sokol Materials & Services (Skillman, NJ)
    …focused on utilities and facility qualification. + Strong understanding of validation principles, methodologies, and regulatory requirements, including FDA , EMA, ... ICH guidelines. Knowledge, Skills & Abilities: + Proficient in risk-based validation approaches. + Strong analytical, problem-solving, and communication skills. +… more
    Sokol Materials & Services (03/26/25)
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  • Principal Scientist - Device Technical…

    Merck (Rahway, NJ)
    …of product design and development; manufacturing process development, qualification, and validation ; and design control and risk management techniques to positively ... development programs ranging from concept generation/selection, development, verification, and validation to launch readiness: + Lead the cross-functional Device… more
    Merck (05/03/25)
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  • Senior Quality Engineer II, Design & Reliability…

    Integra LifeSciences (Princeton, NJ)
    …documentation such as product requirements, schematics, verification, and validation strategy/execution. + Coordinate, review and approve development documentation ... SPC programs with Manufacturing and Quality Control as a part of Process Validation and Design Transfer. + Maintains knowledge of and applies statistical analysis to… more
    Integra LifeSciences (03/31/25)
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  • Technical Writer

    Actalent (Cranbury, NJ)
    …related to ARD/QC operations. This role ensures compliance with regulatory guidelines ( FDA , ICH, USP, EP, cGMP) and in-house standards. You will collaborate closely ... and Analytical Development. + Develop and update analytical test reports/COA's, validation protocols (IQ/OQ/PQ), and stability study reports. + Prepare method … more
    Actalent (05/08/25)
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  • Manager, External Supplier QA-GMP

    Daiichi Sankyo Inc. (Basking Ridge, NJ)
    …commercial and investigational drug product is constantly assessed to comply with FDA premises and regulation, another applicable GMP guidelines and internal DS ... the facility, equipment lab instruments, engineering, maintenance, computerized systems and validation activities which complies with GMP guidelines such as ICH and… more
    Daiichi Sankyo Inc. (05/09/25)
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