CQV Specialist

Job Title: CQV Specialist
Location: MN Onsite
Duration: 12-Month Contract
Employment Type: Contract W2
Pay Rate: $60/hr W2

Job Summary:
We are hiring an experienced CQV Specialist to support commissioning, qualification, and validation activities within a GMP biopharmaceutical manufacturing environment. The role will focus on qualification of upstream and fill-finish manufacturing equipment, including bioreactors, process transfer systems, CIP/SIP systems, and process utilities.

Job Requirements:

• 10+ years of CQV, Validation, Quality, or Engineering experience within pharmaceutical, biotechnology, or life sciences manufacturing.

• Strong hands-on experience authoring and executing IQ/OQ/PQ protocols and validation reports.

• Experience supporting upstream vessels, bioreactors, and/or fill-finish manufacturing lines.

• Experience with CIP/SIP systems, process transfer systems, and process utilities.

• Hands-on experience writing, investigating, and resolving deviations in a GMP environment.

• Experience with commissioning, equipment startup, and qualification activities.

• Knowledge of GMP/cGMP, FDA requirements, CAPA, change control, and risk assessments.

• Strong technical writing, documentation, and cross-functional communication skills.

• Bachelor's degree in Engineering, Life Sciences, Biotechnology, or a related technical discipline.