• Data Analytics Systems Engineer

    Lilly (Branchburg, NJ)
    …operations. Execute with precision, speed, and simplicity, ensuring compliance with Computer Systems Validation policies, standards, procedures, and practices. ... + Oversee and participate in the installation, configuration, and validation of key cGXP dashboards and tools. Develop and...as required and defined. **Basic Requirements:** + BS/BA in Computer Science or related field required + 5+ years… more
    Lilly (10/02/25)
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  • Associate Director, Drug Product, Manufacturing…

    BeOne Medicines (Pennington, NJ)
    …site drug product MST function to support technology transfer, validation , continued process verification, investigations, change management and manufacturing ... CPV program for process performance + Responsible for technical transfer, validation , investigation, and technical support of aseptic manufacturing operations in… more
    BeOne Medicines (09/18/25)
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  • 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)
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  • Sr. Control Systems Engineer - Multiple Shift…

    Roche (Branchburg, NJ)
    …problem solving with regards to the automation systems as well as in the validation of process and facility automation. They may also develop code and design system ... industrial manufacturing equipment for filling & packaging operations in an FDA -regulated manufacturing facility. + Responsible for overall control system concept… more
    Roche (09/26/25)
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  • Associate - System Engineer

    Lilly (Branchburg, NJ)
    …or Werum PAS-X). + Minimum 3+ years experience leading or supporting the Computer System Validation of IT platforms including Data Integrity compliance. + ... FDA regulations for pharmaceutical manufacturing. + Experience with Computer System Validations. + Experience with technical mentoring and developing technical… more
    Lilly (09/27/25)
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  • 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)
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  • Director of Quality

    Innovation Foods LLC (Millville, NJ)
    …government requirements. Act as a liaison for regulatory compliance agencies (USDA, FDA , Kosher, Halal, and others) Coach and counsel employees when appropriate in ... relationships and associated microbiology. Must have experience with filing FDA Scheduled Processes and prior experience with process authorities and… more
    Innovation Foods LLC (08/22/25)
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  • Statistical Programmer (Data & Statistical…

    AbbVie (Florham Park, NJ)
    …Analyst Data Models (ADaM), data sets following CDISC standards for either production/ validation with creating specifications for structure of ADaM data sets for ... for creation of Tables, Listings & Figures for either production/ validation , also responsible for accuracy of SAS programs by...& Experience Must possess a BS in Statistics, Biostatistics, Computer Science or related field, & 2 years of… more
    AbbVie (09/18/25)
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  • Principal Sterilization Microbiologist

    System One (Park Ridge, NJ)
    …+ Sterilization & Microbiological Expertise + Lead development, optimization, and validation of sterilization processes including ethylene oxide, dry heat, gamma ... Leadership & Scientific Rigor + Oversee microbiological method development, validation , and data interpretation for regulatory submissions + Manage complex… more
    System One (09/25/25)
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  • Manufacturing Associate III

    Catalent Pharma Solutions (Princeton, NJ)
    …cell counts, expansion, separation, and cryopreservation, in compliance with cGMP, FDA , and safety regulations. + Develop, finalize, and review production-related ... + Troubleshoot manufacturing processes and equipment issues, partnering with Facilities and Validation to maintain proper functionality. + Serve as a subject matter… more
    Catalent Pharma Solutions (09/17/25)
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