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CQV SME​/Senior CQV Engineer

Job in Springfield, Sangamon County, Illinois, 62777, USA
Listing for: QCS Staffing
Full Time position
Listed on 2026-02-12
Job specializations:
  • Engineering
    Validation Engineer, Pharma Engineer, Process Engineer, Manufacturing Engineer
Salary/Wage Range or Industry Benchmark: 125000 - 150000 USD Yearly USD 125000.00 150000.00 YEAR
Job Description & How to Apply Below
Position: 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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Position Requirements
10+ Years work experience
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