On-Site CQV Engineer for Biopharma Validation

Technical Source

Holly Springs (NC)

On-site

USD 90,000 - 130,000

Full time

4 days ago

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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