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    Validation Engineer - Fort Wayne, United States - EPM Scientific

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    Description

    Title:
    Validation Engineer

    Summary:


    A leading manufacturing company is looking to add a Validation Engineer to their growing team This is a well-established company with over 50 years of experience in the industry, specializing in manufacturing ingredients used in nutrition products.


    The Validation Engineer will be responsible for:
    Perform lab-scale processing and/or data analysis review
    Lead the development and implementation of Change Controls, Deviation investigations and CAPAs
    Execute Installation/Operational/Process Qualification/Process Validation (IQ, OQ, PQ, PV) protocols
    Support the Validation Master Plan and Calibration program activities
    Identify areas of improvements and facilitate the revision and approval of Standard Operation Procedures (SOP), Manufacturing Instructions (MI) and other documents
    Perform risk assessments

    Qualifications:
    6+ years experience in FDA and/or USDA environment
    3+ years experience in validation/qualification
    Knowledge of US FDA 21 CFR Part 117 and Q7 cGMP requirements
    Experienced in equipment qualification, method validation, test method development/validation

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