CQV Project Manager - US, Illinois - 6-12 Month ContractThis 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! #LI-FY1