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CQV Engineer
Job in
Wilmington, New Hanover County, North Carolina, 28412, 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 a CQV Engineer to support commissioning, qualification, and startup activities within a biologics manufacturing facility. This hands‑on role focuses on validation execution, equipment startup, troubleshooting, and GMP documentation in a fast‑paced pharmaceutical environment.
Key Responsibilities- Author, review, and execute IQ/OQ/PQ validation protocols and reports.
- Support equipment commissioning, startup, system walkdowns, and operational readiness.
- Troubleshoot bioprocess equipment and resolve field execution issues.
- Collaborate with Engineering, Quality, Automation, and Operations teams.
- Complete deviations, validation documentation, and GMP records.
- Support commissioning activities using CMMS/work orders and ensure compliance with GMP standards.
- Bachelor's degree in Engineering or related technical field.
- 1–5+ years of CQV, Validation, or Biotech/Pharmaceutical Manufacturing experience.
- Experience with bioreactors, pumps, or large stainless‑steel process equipment.
- Strong knowledge of IQ/OQ/PQ execution, GMP documentation, and equipment troubleshooting.
- Experience with Kneat, Chromatography, UF/DF, or startup/commissioning environments is a plus.
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