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CQV Engineer
Job in
Covington, Kenton County, Kentucky, 41011, USA
Listed on 2026-07-14
Listing for:
United Pharma
Full Time
position Listed on 2026-07-14
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering
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
- 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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