Validation Engineer I/ II - Athens, United States - System One Holdings, LLC

    System One Holdings, LLC
    System One Holdings, LLC Athens, United States

    1 month ago

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    Description
    Job Title: Validation Engineer I/ II

    Location: Athens, GA

    Type: Contract

    Responsibilities
    • Perform Smoke studies and assist in semi annual Media fill qualifications as a SME
    • Perform requalification/periodic review of autoclaves, depyrogenation tunnels, cold rooms, freezers and warehouse areas.
    • Has worked with Ellabs data loggers and software
    • Write and execute protocols and complete final reports.
    • Understanding of cleaning validation concepts and principles.
    • Understands pharma grade utilities ( water HVAC, gases)
    • Support Maintenance, Engineering and Production Depts. in the selection, review, acquisition, and upgrade of systems and production equipment.
    • Provide technical support in developing user and functional requirements specifications, URS, RA, FRS, and DQ for systems and equipment.
    • Develops and Assists with audit responses and completion of assigned CAPAs by target due dates.Included is the responsibility for making sure Validation areas are "inspection ready" at all times.
    • Support Change Control, Deviation and CAPA activities
    Requirements

    Skills:
    • Aseptic processing
    • Protocol generation
    • Sterilization
    • Validation
    • FDA/USDA
    Required:
    • HVAC
    • VALIDATION ENGINEER
    • CGMP
    • FILLING LINES
    • BIOPHARMACEUTICAL
    Education:
    • Bachelors , preferable in a science or engineering related field
    Benefits

    System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.