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    Validation Engineer - Rochester, United States - Insight Global

    Insight Global
    Insight Global Rochester, United States

    3 weeks ago

    Insight Global background
    Manufacturing / Mechanical
    Description

    Day to Day:

    Insight Global is looking for a Validation Engineer to support one of our Medical Device manufacturing clients in Rochester, NY. This position will provide validation support and leadership for the contact lens manufacturing expansion project underway at the site. The Validation Engineer will ensure product and system quality within the contact lens manufacturing operations. The primary responsibility of this position will be to evaluate engineering and mechanical systems based on safety and performance standards. The Validation Engineer is expected to analyze results, maintain activity logs, troubleshoot issues, and ensure compliance with safety and quality regulations. The ideal candidate must be able to understand the current validation strategy already in place, establish testing templates for the various stages, and develop/execute testing protocols to validate product and process reliability.

    Qualifications:

    • 5+ Years of experience as a Validation Engineer
    • Pharmaceutical or Medical Device experience
    • Experience in developing and executing test protocols including FAT, SAT, IQ, OQ, PQ, PV
    • Experience in Mechanical Engineering testing
    • Experience in Process/Equipment validation or Quality Engineering
    • Understanding of Validation Industry Practices including SDLC (Software Development Life Cycle) and Risk Based Validation approach
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