CQV Engineer
Job in
Laconia, Belknap County, New Hampshire, 03246, USA
Listed on 2026-10-02
Listing for:
Intellectt INC
Full Time
position Listed on 2026-10-02
Job specializations:
-
Engineering
Validation Engineer, Pharma Engineer, Quality Engineering
Job Description & How to Apply Below
Job Title: CQV Engineer
Location:
New Hampshire
Duration: 6 Months
Pay Rate: $57 $ 60/hr W2
Industry: Biotech / Pharmaceutical
Seeking an experienced CQV Engineer to support commissioning and qualification of single-use manufacturing systems within a GMP Biotech API/Drug Substance facility. The role requires strong hands-on experience with single-use technologies and upstream/downstream process equipment.
Key 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.
- 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.
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