• Senior Scientist, Device and Combination Product…

    Merck (Rahway, NJ)
    …+ Deep technical understanding of test method development and qualification/ validation techniques. + Fluency with mechanical testing, imaging, and measurement ... including engineering studies, design verification protocols, stability studies and validation protocols, ensuring appropriate selection of acceptance criteria and… more
    Merck (05/08/25)
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  • Quality Assurance Specialist

    Eurofins (North Brunswick Township, NJ)
    …+ Audits various reports prior to issuance (eg analysis reports, method validation reports, research and development reports (as needed), special project reports, ... of USP/EP/JP standards and guidelines. + Moderate understanding of laboratory regulations ( FDA , ISO, GLP, GMP) + Experience with testing of pharmaceutical, cosmetic,… more
    Eurofins (05/08/25)
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  • Senior R&D Microbiologist

    Astrix Technology (Hackensack, NJ)
    …and engineering teams. + Oversee sterilization cycle development, validation , requalification, and implementation for specific products. **Laboratory Operations** ... + Support development of regulatory strategies related to sterilization validation and compliance. **Performance Expectations** + Build strong collaborative… more
    Astrix Technology (05/08/25)
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  • Sr. Project Engineer, SDS

    Fujifilm (Trenton, NJ)
    …to oversee all technical aspects of Synapse product implementation, fromsolution validation phases through product go-live. The Project Engineer (PE) must have ... NFS, CIFS, DAS. + Disaster Recovery (DR) setup and validation : Backupexec, NAS or Tape media. + Plan and...with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard… more
    Fujifilm (04/25/25)
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  • Equipment Engineer

    Sokol Materials & Services (Skillman, NJ)
    …or Science related discipline preferred. + Minimum 3 years of experience in FDA -regulated industry. + Minimum 3 years of experience working directly with laboratory ... of cGMP, GXP, GAMP, including 21CFR part 11, computer systems validation requirements and good documentation practices. + Knowledge of pharmaceutical, manufacturing… more
    Sokol Materials & Services (04/09/25)
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  • Senior Manager, Manufacturing Systems

    BeOne Medicines (Hopewell, NJ)
    …Hopewell Site IT Team. They will be the IT Partner helping with installation, validation and maintenance of various GMP systems such as MES, DCS, EMS. **Essential ... methodologies, 21CFR Part 11 compliance, and GxP computer systems validation (CSV). + Demonstrated track record in Engineering/IT/Pharma supporting manufacturing… more
    BeOne Medicines (04/04/25)
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  • Senior Sterilization Microbiologist

    System One (Park Ridge, NJ)
    …and sterilization theory and practice. + Lead cycle development, validation , requalification activities, as well as product-specific sterilization qualifications and ... + Provide input to regulatory strategies as it relates to sterilization validation and verification Performance Measurements + Ability to work in partnership with… more
    System One (03/28/25)
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  • Senior Project Manager

    Integra LifeSciences (Princeton, NJ)
    …clear communication with stakeholders in manufacturing, quality, engineering, validation , product development, procurement, supply chain, process technologies, ... + Experience in a manufacturing environment, preferably medical device, pharmaceutical or FDA regulated industry. + Must possess strong written, verbal, and people… more
    Integra LifeSciences (02/14/25)
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  • Manager, Cryo Operations, Inventory Management,…

    Bristol Myers Squibb (Summit, NJ)
    …12hr/7d Operation). The position assures individual and group compliance with all FDA , DEA, DOT, ISBT, CTPAT, OSHA, VAWD, cGMPs and applicable policies, regulations ... best industry practices, application of principles, concepts, practices, standards, validation , and qualification. + Strong knowledge of inventory management… more
    Bristol Myers Squibb (05/09/25)
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  • Drug Product Development IT Business Partner

    Bristol Myers Squibb (New Brunswick, NJ)
    …have knowledge of Software Development Lifecycle (SDLC) and of computer systems validation (CSV) + Strong Project Management skills, and experience with agile and ... standards relevant to the BioPharma industry, such as GxP, HIPAA, GDPR, and FDA regulations. + Strong analytical and problem-solving skills, with the ability to… more
    Bristol Myers Squibb (05/08/25)
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