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CQV Engineer

Job in Covington, Kenton County, Kentucky, 41011, USA
Listing for: United Pharma
Full Time position
Listed on 2026-07-14
Job specializations:
  • Quality Assurance - QA/QC
    Quality Engineering
Salary/Wage Range or Industry Benchmark: 90000 - 120000 USD Yearly USD 90000.00 120000.00 YEAR
Job Description & How to Apply Below

We are seeking an experienced CQV Engineer to support a major pharmaceutical expansion project involving the installation and startup of four new secondary and tertiary packaging lines. This hands‑on role focuses on commissioning, qualification, equipment turnover, and operational readiness within a GMP‑regulated manufacturing environment.

Key Responsibilities
  • Lead commissioning and qualification activities for new packaging equipment and manufacturing systems
  • Develop, review, and execute commissioning plans, protocols, test scripts, punch lists, and turnover packages
  • Perform equipment walkdowns, system verifications, and commissioning activities on the manufacturing floor
  • Support Site Acceptance Testing (SAT) and ensure equipment meets design and operational requirements
  • Track and resolve punch list items through final system acceptance and GMP handover
  • Collaborate with Engineering, Manufacturing, Quality, Construction, and equipment vendors throughout project execution
  • Ensure compliance with GMP, FDA, and site quality standards while maintaining complete C&Q documentation
  • Support successful turnover of commissioned systems into routine manufacturing operations
Qualifications
  • Experience in Commissioning & Qualification within Pharmaceutical or Biotech manufacturing
  • Hands‑on experience with packaging equipment, system turnover, SAT, and equipment startup
  • Strong knowledge of GMP regulations, commissioning practices, and manufacturing operations
  • Experience authoring and executing C&Q documentation and coordinating cross‑functional project activities
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