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    Quality Engineer - New York, United States - Premier Life Sciences LLC

    Premier Life Sciences LLC
    Premier Life Sciences LLC New York, United States

    1 week ago

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    Description

    Job Title:
    Validation Engineer Across the USA
    Has understanding of regulations pertaining to the implementation and use of computerized systems in all GxP areas.


    • Participates in system implementation project teams to provide guidance on System Lifecycle activities and validation strategy to be followed using a risk-based approach based on GAMP 5.
    • Reviews and approves system lifecycle deliverables for new and modifications to computerized systems used in the GxP areas
    • Consults with QISM team members and relevant internal stakeholders to identify / define high risk areas with the intent on focusing on patient safety, product quality and data integrity.
    • Identifies and escalates areas of risk or non-compliance to manager / leadership team
    • Participates in performing Periodic Review activities of Computerized Systems
    • Provide support to regulatory inspection preparedness activities as needed
    • Experience performing Infrastructure Qualification activities
    Requirements

    • You've earned your BS in chemical, biomedical, or biochemical engineering, biological sciences, or related field/experience.
    • Experience quality assurance tasks and remediation actives.
    • Experience reviewing Master Batch Records and validation documents.

    Required Skills:
    4 years plus of equipment validation experience in a pharma/GMP environment, must have:
    Temperature mapping
    Chamber requalification
    Clean utilities experience
    Validation experience with HVAC, Utilities, and Vial filling line equipment
    Hands on experience with terminal sterilization and aseptic processing
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