• Director, QA Drug Substance Operations

    Fujifilm (Holly Springs, NC)
    …associated support functions such as Process Science, Engineering Science, Process Engineering, Validation , and Automation + Ensures the quality assurance ... standards + Approves critical lifecycle documentation, including risk assessments, product/ process /equipment specifications, functional specifications,traceability matrices, qualification protocols, validation more
    Fujifilm (08/20/25)
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  • Process & Controls Engineer

    Insight Global (Browns Summit, NC)
    …will be directly supporting a large project and initiative for change management, process control & improvement, validation reporting, and program process ... Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ . Skills and Requirements * Process Improvement, Change Management, and Validation experience.… more
    Insight Global (09/09/25)
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  • Jt065 - Quality Applications Specialist

    Quality Consulting Group (Villalba, PR)
    …Rico & USA. Responsibilities: + Support product transfer activities, mainly focus on process validation , DV testing build and release product up to commercial ... release. + Conducts a compliant validation process for quality information technology systems which requires formal validation documentation (including… more
    Quality Consulting Group (10/23/25)
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  • Senior Vehicle Development Engineer

    ROUSH (Allen Park, MI)
    …Lead development of engineering specifications, testing procedures, vehicle level DVPs (Design Validation Plans), PVPs ( Process Validation Plans), CDPs ... of DFMEAs (Design Failure Mode and Effect Analysis), DVPs (Design Validation Plans), PVP ( Process Validation Plans), vehicle requirements and test procedures… more
    ROUSH (10/04/25)
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  • Design Quality Engineer

    Philips (Colorado Springs, CO)
    …**In this role you** You are responsible for creating and executing comprehensive process validation strategies to ensure new products transition seamlessly to ... to quality and regulatory standards. The role executes the full design control process , including validation and design transfer, and ensures accurate and… more
    Philips (09/11/25)
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  • Manager, CQV

    Fujifilm (Holly Springs, NC)
    …and supported through servant leadership * Creates and implements the strategy for process equipment validation lifecycle, such as Validation Master Plan ... at the Holly Springs facility. This role is crucial for Upstream and Downstream process equipment (thaw to bulk fill) as it enables the right first time and… more
    Fujifilm (08/08/25)
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  • Manager - Tech Transfer , MTS

    PCI Pharma Services (Bedford, NH)
    …to ensure successful transfer of processes to manufacturing sites. + Support process characterization studies, process validation activities, and risk ... between MTS Process Specialists Team, MTS management, Project Management, Process Development, Purchasing, Validation , Quality, Safety & Manufacturing teams.… more
    PCI Pharma Services (10/22/25)
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  • Associate Director, MSAT, Downstream Drug…

    Otsuka America Pharmaceutical Inc. (Frankfort, KY)
    …environments and regulatory requirements (FDA, EMA, ICH). + Familiarity with process validation principles and CPV. + Strong analytical, problem-solving, ... and compliance of downstream operations through effective technology transfer, validation support, process monitoring, troubleshooting, and lifecycle management… more
    Otsuka America Pharmaceutical Inc. (10/17/25)
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  • Jt562 - Sr Engineer

    Quality Consulting Group (Juncos, PR)
    …batch records, automation, materials, new equipment introduction/modifications, cleaning, changeover, process validation , training, and floor readiness. + ... actions as needed. + Assist in the development and execution of process validation protocols and reports. + Collect, analyze, and interpret process more
    Quality Consulting Group (10/16/25)
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  • Associate Director, Drug Product, Manufacturing…

    BeOne Medicines (Pennington, NJ)
    …+ Expertise in late stage/commercial biopharmaceutical Drug Product technology transfer, process characterization and process validation . + Experience ... the site drug product MST function to support technology transfer, validation , continued process verification, investigations, change management and… more
    BeOne Medicines (09/18/25)
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