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Parsippany

    Validation Engineer - Parsippany, United States - Insight Global

    Insight Global background
    Pharmaceutical / Bio-tech
    Description

    Responsibilities:

    We are in search of a seasoned Senior Validation Specialist to become part of a major pharmaceutical client's team on a full-time basis. The role involves being present on-site in Parsippany, NJ for five days a week. The key responsibility of this role is to ensure the quality and compliance of pharmaceutical equipment. The ideal candidate will possess expertise in creating validation protocols for different process equipment and systems, as well as conducting validation tests in accordance with established protocols (IQ, OQ, PQ).

    Requirements:

    • 2+ years of experience as a Validation specialist or engineer in the Pharma or Biopharma industry
    • Experience in executing and drafting test protocols for Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)
    • Thorough understanding of production processes
    • Familiarity with CAPA's and Deviation Investigations
    • Proficiency in Trackwise, Veeva, or similar Quality Management Systems

    Equipment:

    • 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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