CQV SME / Senior CQV Engineer

CQV SME / Senior CQV Engineer - 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:

• Serve as the technical SME for CQV activities related to PFS lines (Pre-filled Syringe) and Process Equipment.
• Lead and execute commissioning, qualification, and validation deliverables including URS, FAT/SAT, IOQ, PQ, and summary reports.
• Provide expert troubleshooting and engineering support during equipment startup, qualification, and early operations.
• Partner closely with engineering, automation, operations, and quality teams to ensure equipment readiness and compliance.

What you'll need:

• Extensive CQV experience in pharmaceutical or biotech manufacturing.
• Demonstrated SME‑level experience with PFS equipment, isolators, and aseptic filling technologies. (Pre-Filled Syringe Lines)
• Strong experience participating in or leading FAT/SAT activities with equipment vendors.
• Proven ability to lead complex CQV activities with minimal oversight.

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