| Location | NULL, MN |
| Salary | $55–$60 |
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.