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    Senior Quality/Validation Engineer - Los Angeles, United States - Meet

    Meet
    Meet Los Angeles, United States

    1 week ago

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    Description

    An exciting clinical-stage biotech company, located in the Los Angeles area, is seeking a talented professional to join a their team as a Senior Quality Engineer.

    Key Responsibilities:

    • Ensure continuous validation of Equipment, Facilities, Utilities, and Computer Systems.
    • Spearhead validation initiatives to accommodate new equipment and systems in alignment with site expansion and lifecycle demands.
    • Oversee and conduct thorough reviews and approve CQV and system lifecycle documents, ensuring compliance with protocols.
    • Maintain quality control over validation and qualification procedures, addressing deviations, CAPAs, and change controls.
    • Support vendor qualifications, regulatory inspections, and audits
    • Collaborate within cross-functional teams to commission manufacturing, warehousing, and QC testing facilities and equipment.
    • Support quality assurance activities, including Operational Excellence initiatives and management reviews, as required.

    Basic Requirements:

    • Bachelor of Science with 3 years of experience min
    • Familiarity with industry standards and regulatory guidelines from FDA, EMA, and ICH.
    • Proficiency in GMP and quality management systems.
    • Experience in Facility Design and Improvement, along with associated validation requirements.
    • Demonstrated expertise in validating temperature-controlled units and conducting smoke studies.
    • Ability to operate in controlled & classified cleanroom environments.
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