Senior Commissioning Engineer - Spring House - Brooksource

    Brooksource
    Brooksource Spring House

    2 days ago

    Pharmaceutical / Bio-tech
    Description

    Senior Commissioning & Qualification Engineer – Automation (Biopharma Build)

    Owner's Representative | Onsite – Spring House, PA

    Contract through end of year, potential for ongoing extensions

    We are seeking a senior Commissioning & Qualification (C&Q) Automation SME to support the delivery of a state-of-the-art Cell & Gene Therapy manufacturing facility.

    This is a high-visibility, onsite role where you will serve as the Owner's Representative, ensuring highly automated GMP process systems are properly commissioned, integrated, and inspection-ready. If you thrive in complex, automation-heavy capital projects, this is the type of build that defines careers.

    What You'll Be Doing

    • Act as the technical SME for commissioning automated process equipment
    • Represent the owner's interests across all project phases
    • Lead execution of Commissioning Plans with emphasis on automation, integration, and data integrity
    • Author and review IQ/OQ/PQ protocols, URS, and validation documentation
    • Oversee startup and field execution for complex equipment platforms
    • Drive resolution of automation-related deviations and integration issues
    • Coordinate across automation, construction, validation, quality, and vendor teams
    • Apply risk-based qualification principles (ASTM E2500, FMEA)
    • Ensure compliance with GMP, FDA, and 21 CFR Part 11
    • Support digital validation platforms (e.g., Kneat)

    Equipment & Systems Scope

    • Cell & gene therapy manufacturing systems
    • Fill/Finish lines
    • Isolators
    • Integrated process equipment platforms
    • PLC / SCADA / DCS automation layers

    What We're Looking For

    Required:

    • Bachelor's degree in Engineering or Life Sciences
    • 5–10 years of CQV experience in automated biopharma manufacturing
    • Hands-on experience with process equipment and control systems
    • Strong understanding of GMP validation lifecycle

    Strongly Preferred:

    • DeltaV, Rockwell, Siemens, or similar DCS/PLC platforms
    • Experience in greenfield or large capital projects
    • ASTM E2500 / GAMP 5 knowledge
    • Experience with digital validation tools (Kneat, Veeva)
    • Background in cell & gene therapy, fill/finish, or cleanroom environments

    Why This Role?

    • High-impact, automation-heavy greenfield project
    • Owner-side authority and visibility
    • Complex, integrated GMP systems
    • Opportunity to shape commissioning strategy at a flagship facility

    EEO Statement:

    • Eight Eleven Group provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, national origin, age, sex, citizenship, disability, genetic information, gender, sexual orientation, gender identity, marital status, amnesty or status as a covered veteran in accordance with applicable federal, state, and local laws.

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