Senior CQV Engineer

Katalyst Healthcares & Life Sciences • Wichita, KS, US • published 2026-09-19 05:37:23.283979

Description

**Job Description:** We are seeking an experienced Senior CQV Engineer to lead and execute Commissioning, Qualification, and Validation (CQV) activities for pharmaceutical, biotechnology, or life sciences manufacturing facilities. The role will support equipment, utilities, facilities, and manufacturing systems while ensuring compliance with GMP, FDA, GxP, and applicable industry standards. **Responsibilities:** * Lead Commissioning, Qualification \& Validation (CQV) activities for manufacturing equipment, utilities, facilities, and systems. * Develop and execute URS, DQ, FAT, SAT, IQ, OQ, and PQ documentation and protocols. * Develop CQV plans, validation strategies, protocols, reports, and traceability documentation. * Review engineering specifications, P\&IDs, drawings, equipment documentation, and vendor packages. * Coordinate and execute FAT/SAT activities with vendors, Engineering, Quality, and project teams. * Perform equipment and utility qualification activities in accordance with approved procedures. * Develop and execute risk assessments, including FMEA and criticality assessments. * Ensure validation activities are aligned with GMP/GxP, FDA, EU GMP, GAMP 5, and ISPE req...

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