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    Senior CQV Engineer - Raleigh, United States - i-Pharm GxP

    i-Pharm GxP
    i-Pharm GxP Raleigh, United States

    3 weeks ago

    Default job background
    Description
    Senior CQV Engineer - SME Optima Vial Filling Line (contract)

    Summar y

    This is a subject matter expert (SME) contract role responsible for overseeing the installation, commissioning, qualification, and validation of an Optima washing, filling, and stoppering line for vial filling operations.

    The Senior CQV Engineer will ensure the line meets all quality, regulatory, and client requirements throughout the installation lifecycle.

    Key Responsibilities
    Act as the technical lead and SME for the Optima vial filling line installation project
    Generate, review, and approve all associated qualification and validation documentation
    Oversee equipment installation from landing through Site Acceptance Testing (SAT)
    Verify installation compliance with standards, workmanship requirements, and client expectations
    Liaise with equipment manufacturers, Optima engineering teams, and project owners
    Assist site personnel (tech ops, quality, validation, production, maintenance) in understanding equipment operation
    Support development of test plans, procedures, and preventative maintenance schedules
    Collaborate with A&E firms and construction teams to resolve installation issues
    Ensure critical systems meet all quality and regulatory requirements

    Qualificati ons
    Extensive experience with Optima vial filling equipment installation and validation
    Comprehensive knowledge of GXP regulations and industry best practices
    Excellent communication and documentation skills
    Ability to interface with cross-functional teams at all levels
    Strong problem-solving and troubleshooting abilities
    Self-motivated with keen attention to detail
    Ability to travel to installation site as needed

    Education and Experi ence
    BS degree in Engineering, Science or related technical field
    7-10 years of experience in pharmaceutical/biotech equipment validation
    Prior experience as a CQV SME for aseptic filling lines

    heavily preferred

    #J-18808-Ljbffr

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