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Parsippany

    Validation Engineer - Parsippany, United States - Insight Global

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    Insight Global background
    Description

    Day to Day:
    Insight Global is seeking an experienced Sr. Validation Specialist to join one of our large pharmaceutical clients for a full time position. This position will be 5 days a week onsite, in Parsippany, NJ. This individual will play a crucial role in ensuring quality and compliance of pharmaceutical equipment. The ideal individual will have experience developing validation protocols for various process equipment and systems. This individual will have to execute validation test according to established protocols (IQ, OQ,PQ).

    Must-Haves
    2+ years Validation specialist or engineer within Pharma or Biopharma
    Experience executing and writing test protocols Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)
    Comprehensive knowledge of production processes
    Knowledge of CAPA's and Deviation Investigations
    Experience with Trackwise or Veeva or a similar QMS

    Below is a list of all the equipment this team works on:

    Temperature Controlled Units – reach-in and walk-in units
    Sterile filling isolator
    Vaporized Hydrogen Peroxide Chambers / equipment with VHP cycles
    Media Fills for freeze dried and liquid filled sterile vial processes
    Utility commissioning – critical utilities – WFI, Pure Steam, Sterile Comp Air, Clean N2
    HVAC commissioning
    Single Use compounding systems
    QC Analytical, Bioanalytical and QC Micro instrument qualification
    Parts Autoclaves
    Parts Washers
    Packaging equipment (e.g. vial labelers, cartoners)

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