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    Validation Engineer - Athens, United States - Cynet Systems

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

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