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CQV Lead

  1. North America, United States
North Carolina
  1. Contract
Competitive
  1. CAPEX Projects
36398
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CQV Lead - North Carolina - 12 Months Contract

Our client, a globally recognized pioneer in Biotechnology, are recruiting for the position of CQV Lead. A leader in the industry, our client focuses on areas of high unmet medical need and leverages its expertise to stride for solutions. This is your chance to join them on their global mission to better the lives of those effected by disease and illness. The project at hand is for the construction of a new build biomanufacturing plant based located on the East Coast.

Essential duties and responsibilities for this role include, but are not limited to, the following:
  • Develop and implement the CQV strategy for a $1 billion greenfield project, ensuring compliance with regulatory and operational requirements for equipment in one of the following areas: Upstream, Downstream, Buffers, Media Prep,Purification, Clean Utilities, and Black Utilities.
  • Lead the full CQV lifecycle, from early design phases through execution, qualification, and operational readiness.
  • Define the CQV strategy, including risk-based approaches, qualification requirements, and validation master plans.
  • Build and lead a high-performing CQV team, overseeing staffing, resource allocation, and performance management.
  • Utilize Kneat for digital validation and documentation management.
  • Ensure alignment with industry regulations, company policies, and best practices in commissioning and validation.
  • Collaborate closely with engineering, construction, and manufacturing teams to ensure smooth integration of CQV activities.
  • Drive project execution, maintaining timelines, budgets, and quality expectations.
Desirable Experience:
  • Extensive experience in CQV project management within the biopharmaceutical or life sciences industry.
  • Proven experience leading CQV efforts for large-scale greenfield drug substance projects ($500M+).
  • End-to-end project delivery experience, from design through operational handover.
  • Expertise in defining and executing CQV strategies for complex manufacturing facilities.
  • Kneat expertise is required.
If this role is of interest, please apply now.
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