• Senior Manager CQV

    J&J Family of Companies (Titusville, NJ)
    …and Re-qualification, as well as PQ activities * In partnership with E&PS own Computer Systems Validation , including writing and driving CSV protocols, ... the Project Validation Master Plan (PVMP) and ensure on-time qualified system turnover to the end user. **Key Responsibilities:** * Ownership for the development… more
    J&J Family of Companies (09/17/25)
    - Related Jobs

  • 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 ... Physical Requirements : + Prolonged periods of sitting and computer use. + Must be able to lift up...AND RESPONSIBILITIES * Develop and execute commissioning, qualification, and validation protocols for equipment, facility systems , and… more
    Sokol Materials & Services (07/24/25)
    - Related Jobs

  • 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 (09/23/25)
    - Related Jobs

  • Associate Director, Drug Product, Manufacturing…

    BeOne Medicines (Pennington, NJ)
    …+ Health Authority Interaction/Audits + OE and/or LEAN Methodologies + Distributed Control system / Control Systems + Deviation Assessments / Investigations + ... dedicated gowns, depending on area. + Work with hazardous materials and chemicals. ** Computer Skills:** Familiarity with computer -based systems . Word, Excel,… more
    BeOne Medicines (09/18/25)
    - Related Jobs

  • Sr. Analyst, QC Chemistry, US Site (Hopewell, NJ)

    BeOne Medicines (Pennington, NJ)
    …intermediates and finished biological products (monoclonal antibodies) under FDA /EU regulations, applicable International Regulations, and BeOne Medicines' processes ... preventive actions (CAPAs). + Participate in transfer and method validation activities, including protocol preparation, protocol execution, and report preparation.… more
    BeOne Medicines (09/30/25)
    - Related Jobs

  • Equipment Engineer

    Bristol Myers Squibb (Summit, NJ)
    …+ Knowledge of cGMP, GXP, GAMP, SDLC regulations, including 21CFR part 11, computer systems validation requirements and good documentation practices. + ... Advanced knowledge of pharmaceutical, manufacturing and laboratory systems and equipment. + Strong written and verbal communication skills. + Excellent interpersonal… more
    Bristol Myers Squibb (10/02/25)
    - Related Jobs

  • Sr. Manager, Design Assurance & Reliability…

    Integra LifeSciences (Princeton, NJ)
    …+ Participate in design and change control activities. + Participate in FDA inspections, ISO Certification and Surveillance audits and Internal audits. + Collaborate ... product development, product realization, design transfer, design verification and validation . + Experience leading engineering product development teams, experience… more
    Integra LifeSciences (09/04/25)
    - Related Jobs

  • Director of Quality

    Innovation Foods LLC (Millville, NJ)
    …Plant Director and leadership team to improve Quality & Food Safety systems in response to organizational performance, changing regulations, and customer demands. ... product to ensure customer specifications are met. Oversee Quality Assurance systems to satisfy internal and customer requirements to include process evaluation… more
    Innovation Foods LLC (08/22/25)
    - Related Jobs

  • Automation Engineer

    Hovione (East Windsor, NJ)
    …to: Performs assembly, qualification and automation of facilities, equipment and utility systems according to regulatory demands (cGMPs, FDA requirements, etc.), ... and internal procedures. Contributes to the continuous improvement of systems to improve operations, providing them with the necessary...and procedures in place - Ensure the change management system is applied correctly and confirm that prior to… more
    Hovione (08/08/25)
    - Related Jobs

  • Specialist, Quality Compliance

    Integra LifeSciences (Plainsboro, NJ)
    …shall participate in the development, review and/or approval of various Quality System Documentation to ensure that the development, manufacture and distribution of ... and approve quality documents requiring QA oversight (eg, IOPQ and validation protocols, Engineering Change Orders (ECO), deviations, OOS/OOT reports, DHR, Supplier… more
    Integra LifeSciences (07/19/25)
    - Related Jobs