What are the responsibilities and job description for the Sr. CQV Engineer position at Stellar Consulting Solutions, LLC?
Job Title: Sr. CQV 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.