CQV Engineer

Technical Source is currently in search of a CQV Engineer for a biopharmaceutical manufacturing client in the Holly Springs, NC area. This is a long-term contract position that requires on-site work. The qualified candidate will support the Commissioning, Qualification and Validation of process equipment, utilities and facility systems in a cGMP environment.

Responsibilities of the CQV Engineer include:

Develop and execute commissioning and qualification protocols (IQ/OQ/PQ) for process equipment, utilities and HVAC Perform field walkdowns, punch lists and turnover package reviews Conduct temperature mapping and support automation (BAS/DeltaV) testing Manage deviations and discrepancies and write summary reports Use paperless validation software (KNEAT or similar) Work with Engineering, Quality and Operations to meet project milestones Qualifications of the CQV Engineer include:

Bachelor's degree in Engineering or a related field 3+ years of CQV experience in pharmaceutical or biotech manufacturing Working knowledge of cGMP, GDP and the validation life cycle (ASTM E2500 a plus) Experience with KNEAT or another paperless validation system preferred *No C2C or sponsorship is available at this time*

*Compensation will scale based on experience and fit*