CQV Engineer
Listed on 2026-07-01
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Engineering
Quality Engineering, Process Engineer, Manufacturing & Industrial Operations, Validation Engineer -
Manufacturing / Production
Quality Engineering, Manufacturing & Industrial Operations, Validation Engineer
CQV Engineer
Location:
Cincinnati, OH (Onsite) Duration:
Long Term Client:
Client
1. Led CQV activities for utilities, process/manufacturing equipment, automation systems, and fill/finish lines in compliance with FDA (21 CFR 210, 211, 820), ISO 13485/9001, and cGMP regulations.
2. Authored and executed Commissioning, IQ, OQ, and PQ protocols for critical equipment such as autoclaves, lyophilizers, vial washers, isolators, fillers, HVAC systems, and packaging lines.
3. Conducted utility qualifications for purified water, clean steam, compressed gases, and HVAC systems ensuring consistent operational performance
4. CQV Engineer with the capability to drive assigned projects to completion
5. Comprehensive knowledge of the CQV lifecycle
6. Experience with clean utilities (water/compressed air), secondary packaging systems, and cleanroom qualification
7. Familiarity with the V-model approach, which is currently implemented within the project
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