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*