Sr. CQV Engineer
Listed on 2026-06-03
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Engineering
Quality Engineering, Validation Engineer
Locations:
Indianapolis IN/Kansas City KS (Onsite)
Duration: 6 months (Contract to Hire)
Depth of
Experience:
Mid to Senior level (typically 3–10+ years in CQV within pharmaceutical manufacturing)
Job Description:
Develop, execute, and document commissioning, qualification, and validation protocols (IQ/OQ/PQ) for new and modified equipment, utilities, and facilities.
Author and review qualification documents, test scripts, deviation reports, and summary reports.
Perform risk-based commissioning and qualification activities in accordance with FDA, EMA, and internal quality standards.
Coordinate closely with engineering, quality assurance, validation, and operations teams throughout the C&Q lifecycle.
Support technology transfer, process validation, and handover to manufacturing.
Participate in deviation investigations, CAPA implementation, and continuous improvement of CQV processes.
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