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    Senior Validation Engineer - Parsippany, United States - Katalyst HealthCares & Life Sciences

    Katalyst HealthCares & Life Sciences
    Katalyst HealthCares & Life Sciences Parsippany, United States

    3 weeks ago

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    Description
    Responsibilities:
    • Lead and manage multiple commissioning / qualification / validation activities performed at facility with minimal supervision.
    • Equipment Qualification / Re-Qualification (IQ, OQ, PQ) for process equipment, QC equipment, packaging equipment, clean utilities.
    • Cleaning Verification / Validation studies for transferred products.
    • Media Fills / process simulations protocols.
    • Engineering protocols to support packaging validation / shipping study activities.
    • Trackwise deviations and qualification / validation deviations related to equipment / instrument, cleaning, and process non-conformances.
    • Assist in execution of Process Validation and Engineering studies.
    • Review commissioning, qualification, validation projects performed by Validation Specialists and / or Validation contractors.
    • Generate Validation Master Plans (VMPs) and Risk Assessments related to large level qualification projects.
    • Monitor and track protocol and report status.
    • Complete GMP Impact Assessments, System Component Criticality Reviews, Traceability Matrixes, Design Qualification, Vendor documentation checklists, and final handover of documents to Operations with minimal supervision.
    • Mentor and train junior level Validation Specialists on various validation tasks.
    • Plan and complete commissioning, qualification, and validation activities performed in facility.
    • Complete Trackwise deviations and qualification / validation deviations related to equipment / instrument, cleaning, and process non-conformances, and assist Validation Specialist with same activities.
    • Resolve observation / CAPAs generated from internal and external cGMP audits related to Validation, Qualification, and Commissioning studies.
    • Participate and able to answer questions during intern and external audits, as needed.
    • Close change controls, CAPAs, and investigations, as well as ensure deviations, CAPAs, and change controls issued to the department(s) are tracked (closed on time, or extended if necessary.)
    • Prepares Final Reports summarizing the results of executed Validation / Qualification studies and address comments and questions from reviewers / approvers.
    • Assist Production, Engineering, and/ or IT in improving / optimizing performance of process / packaging equipment.
    • Update yearly Validation Master Plan.

    Requirements:

    • Bachelor's degree in engineering or related field, or equivalent combination of education and work-related experience, required.
    • Minimum 5 years of hands-on experience in validation (PV, CV), specifically within the pharmaceutical sector.
    • Subject matter expert in at least two (2) of the Qualification / Validation subjects specified below
    • Sterile Process Equipment Qualification
    • Packaging Equipment Qualification
    • Media Fills
    • Utilities Commissioning / Qualification
    • Cleaning Verification / Validation
    • Process Validation
    • QC Equipment Qualification
    • Computer System Validation
    • Environmental Monitoring Qualification of Classified Areas
    • Understanding of validation principles, current Good Manufacturing Practices (cGMP), and applicable regulatory requirements
    • Proficiency in equipment and process validation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
    • Excellent problem-solving and analytical skills.
    • Strong communication and teamwork abilities.
    • Ability to work independently in a timely manner.
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