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CQV Package Owners

  1. North America, East Coast
North Carolina
  1. Contract
Competitive
  1. Life Sciences
37872
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CQV Package Owners - US, North Carolina - 2+ Years Contract

Our client, a global pharmaceutical manufacturing organization are looking for a talented CQV Package Owners to join their expanding team. With continued organizational growth and considerable investment across their portfolio and capital programs this is an extremely exciting opportunity to contribute towards their brand-new manufacturing facility on the East Coast of the United States.

Essential Duties and Responsibilities for this role include, but are not limited to:
  • Lead and manage the full equipment lifecycle and engineering scope for greenfield drug substance manufacturing lines.
  • Work closely with cross-functional teams, including design, equipment, and construction, to ensure timely and effective execution.
  • Act as the technical Subject Matter Expert (SME) in the discipline process.
  • Oversee the design and specifications of process equipment, ensuring they meet project requirements.
  • Coordinate Factory Acceptance Tests (FATs) and Site Acceptance Tests (SATs) for equipment.
  • Provide technical support and expertise throughout the project lifecycle, from design to start-up and handover.
  • Review and recommend improvements to processes and procedures to ensure optimal efficiency and compliance with industry standards.
  • Ensure the integration of process systems and equipment aligns with client's quality standards and regulatory requirements.
  • Support commissioning and qualification efforts for equipment.
 Requirements:
  • Requires a strong level of extensive experience in process engineering, CQV, or project management, with a strong focus on drug substance biologics projects.
  • Candidates with reliable/proven experience and a solid background may also be considered.
  • Experience in package of equipment of $100-200m
  • Experience of managing up to 60 people
  • Greenfield project experience
If you are interested, please apply now for immediate consideration and further information.

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