Title: CQV Engineer
Location: NH
Duration: 6 months
Pay Rate: $59/Hr - $64/HrProject: Our client is seeking a CQV Engineer to support the commissioning and qualification of single-use manufacturing systems within a GMP Biotech API/drug substance facility. This individual will be responsible for CQV activities associated with single-use equipment and components, with a particular focus on single-use vessel/bag liners, tube sets, assemblies, and associated process equipment. Responsibilities will include reviewing design and vendor documentation, developing and executing qualification protocols, performing field verification and testing, resolving discrepancies and deviations, andsupportingsystemturnovertomanufacturing.
Requirements Extensive experience qualifying single-use technologies, including vessel/bag liners, tube sets, and disposable assemblies within Biotech API Manufacturing
Experience with bioreactors, mixing vessels, filtration/TFF, chromatography, and other upstream/downstream process systems
Experience authoring and executing IQ/OQ and commissioning protocols
Strong understanding of GMP requirements, deviations, change control, and validation documentation
Benefits:
This a contract position does not include employer-provided benefits.
Equal Opportunity Employer:
We are an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to
race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Background Check:
Background checks may be conducted in accordance with applicable law.
Work Authorization:
Applicants must be authorized to work in the United States.