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    Head of Engineering - Raleigh, United States - CARsgen Therapeutics

    CARsgen Therapeutics
    CARsgen Therapeutics Raleigh, United States

    3 weeks ago

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    Description

    Key Responsibilities:

    • Facility design and renovation.
    • Construction project management.
    • Harmonization of facility engineering systems and maintenance and HSE procedures and practice.
    • Office accommodation/Cleanroom manufacturing space/Warehousing.
    • Ensure equipment life cycle maintenance, manufacturing facility cleaning activities planning timeliness, building maintenance, and enforcement of safety and security measures.
    • Develop and implement comprehensive engineering, maintenance, and facility strategy for multiple buildings as well as the supporting policies and procedures.
    • Partner with key stakeholders including Manufacturing, Technology Transfer and Support, Process Development, and Quality to meet user requirements and optimal functioning of all manufacturing, laboratory, and building spaces.
    • Act as a subject matter expert for review, approval, and updating of critical building documentation, including Architectural Plans/Drawings, Engineering Drawings, Piping & Instrumentation Drawings (PID), Facility Maps/Diagrams, GMP Process Drawings, IT Network Documentation/Diagrams.
    • Compliance with all state, federal, and regulatory governing agencies.

    Requirements:

    • Leadership experience in designing, building, and validating facilities associated with phase 1 to 3 manufacturing, pre-positioned to be commercially compliant, inspection ready and licensable by USFDA and EMA health authorities.
    • Experience overseeing FDA regulated manufacturing facilities management projects.
    • Design and maintain clean room ISO 7 and above, GMP Calibration, Metrology, HVAC, electrical systems, plumbing systems.
    • Bachelor's Degree.
    • 5+ years of high-level managerial experience within one or more areas including Construction, Process, Engineering, Facilities/Engineering Maintenance.
    • 3+ years of Biotech experience.
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