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    Validation Engineer - Athens, United States - Sigma

    Sigma
    Sigma Athens, United States

    16 hours ago

    Default job background
    Description
    Validation Engineer, Athens,GA 7+ months

    Sigma Systems is currently looking for a Validation Engineer

    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:
    • Bachelors , preferable in a science or engineering related field
    • Aseptic processing
    • Protocol generation
    • Sterilization
    • Validation
    • FDA/USDA
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