CQV Engineer — Biotech Single-Use Systems

Intellectt INC; New Hampshire; On-site; USD 79,000 - 83,000; Full time

Job summary

Intellectt INC is seeking an experienced CQV Engineer to support commissioning and qualification of single-use manufacturing systems within a GMP Biotech API/Drug Substance facility in New Hampshire. The role requires hands-on CQV expertise with single-use technologies.

You will perform CQV activities for single-use equipment, vessels, and disposable assemblies, review specifications, author IQ/OQ protocols, and ensure field verification and documentation readiness for GMP manufacturing.

Qualifications

• Strong hands-on CQV experience in Biotech API/Drug Substance manufacturing.
• Extensive experience qualifying Single-Use Technologies (SUT), including vessel/bag liners, tube sets, and disposable assemblies.
• Experience with bioreactors, mixing vessels, filtration/TFF, and chromatography systems.
• Strong experience authoring and executing Commissioning and IQ/OQ protocols.
• Knowledge of upstream and downstream bioprocessing equipment.
• Strong understanding of GMP, deviations, change control, and validation documentation.

Responsibilities

• Perform CQV activities for single-use equipment, vessel/bag liners, tube sets, and disposable assemblies.
• Review design specifications, vendor documentation, and equipment documentation.
• Author and execute commissioning and IQ/OQ protocols.
• Perform field verification, testing, and equipment qualification activities.
• Support qualification of bioreactors, mixing vessels, filtration/TFF, chromatography, and related process systems.
• Investigate and resolve discrepancies and deviations during CQV execution.
• Support system turnover and readiness for GMP manufacturing.
• Maintain compliant validation and qualification documentation.

Skills

CQV experience

Single-Use Tech

Bioprocess equipment

GMP knowledge

IQ/OQ protocols

Job description

Intellectt INC is seeking an experienced CQV Engineer to support commissioning and qualification of single-use manufacturing systems within a GMP Biotech API/Drug Substance facility in New Hampshire. The role requires hands-on CQV expertise with single-use technologies.

You will perform CQV activities for single-use equipment, vessels, and disposable assemblies, review specifications, author IQ/OQ protocols, and ensure field verification and documentation readiness for GMP manufacturing.