CQV Engineer

Technical Source; Holly Springs (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

Technical Source is seeking a CQV Engineer for a biopharmaceutical manufacturing client in the Holly Springs, NC area. This long-term, on-site contract role involves supporting commissioning, qualification and validation of process equipment, utilities and facility systems in a cGMP environment.

The candidate will develop IQ/OQ/PQ protocols, perform field walkdowns, lead temperature mapping and support BAS/DeltaV testing while managing deviations and coordinating with Engineering, Quality and

Qualifications

• 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.

Responsibilities

• 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

Skills

CQV experience

cGMP knowledge

Paperless validation

BAS/DeltaV testing

Education

Bachelor's degree in Engineering or related field

Tools

KNEAT

Paperless validation systems

Job description

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*