Description: Commissioning & Qualification (C&Q)
Locations: Indianapolis IN, Kansas City KS, St. Louis MO, Columbus OH

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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