Sr. CQV Enginner

Job Title: Sr. CQV Engineer

Locations: Indianapolis IN/Kansas City KS

Duration: 6 months

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.