CQV Project Manager

CQV Project Manager - US, Illinois - 6-12 Month Contract

This innovative organisation is a global leader in the development and manufacturing of high-quality sterile injectable products, offering solutions tailored to meet the needs of both clinical and commercial markets. With a strong focus on cutting-edge technologies, they are actively driving advancements in drug substance manufacturing. 

What you'll do:

• Lead, plan, and manage all CQV activities for assigned systems and equipment, ensuring compliance with cGMP, FDA, EU, and site quality standards.
• Develop and execute CQV strategies, schedules, and documentation (URS, FAT/SAT, IOQ, PQ, summary reports).
• Coordinate cross-functional teams including engineering, operations, quality, automation, and vendors.
• Provide technical oversight and troubleshooting during commissioning and qualification phases.

What you'll need:

• Extensive CQV experience in pharmaceutical or biotech manufacturing.
• Demonstrated experience with PFS equipment, aseptic processing, and isolator technology.
• Strong understanding of cGMP, GAMP 5, ASTM E2500, and regulatory expectations.
• Proven ability to manage complex projects and cross-functional teams.

If this role is of interest to you, please apply now!
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