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    Validation Engineer - New York, United States - eTeam

    eTeam
    eTeam New York, United States

    3 weeks ago

    eTeam background
    Pharmaceutical / Bio-tech
    Description

    Job Title:
    Validation Engineer


    Location:
    Athens, GA

    Duration: 06 months


    Duties:


    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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