CQV Engineer

Job Title: CQV Engineer Single-Use Systems

Location: New Hampshire

Duration: 6 Months

Employment Type: W2

Job Summary

We are seeking an experienced CQV Engineer to support commissioning and qualification of single-use manufacturing systems within a GMP Biotech API/Drug Substance facility.

Responsibilities:

• Support commissioning and qualification of single-use manufacturing systems.
• Develop and execute commissioning, IQ, and OQ protocols.
• Review design specifications and vendor documentation.
• Perform field verification, testing, and equipment walkdowns.
• Investigate and resolve discrepancies and deviations.
• Support system turnover to Manufacturing and maintain GMP-compliant documentation.

Requirements:

• Bachelor's degree in Engineering, Life Sciences, Biotechnology, or a related technical/scientific discipline.
• 5+ years of CQV experience in biotech/biopharmaceutical manufacturing.
• Hands-on experience qualifying single-use technologies.
• Experience with vessel/bag liners, tube sets, and disposable assemblies.
• Experience with bioreactors, mixing vessels, filtration/TFF, and chromatography systems.
• Strong experience authoring and executing IQ/OQ and commissioning protocols.
• Knowledge of upstream/downstream process equipment and Drug Substance/API manufacturing.
• Strong understanding of GMP, deviations, change control, and validation documentation.