Job Title: CQV Specialist
Location: Brooklyn Park, MN
Duration: 12-Month Employment Tyep: W2Job SummarySeeking an experienced CQV Specialist to support commissioning, qualification, and validation activities in a GMP biomanufacturing environment. The role will focus on equipment qualification, validation protocols, deviations, and investigations across upstream and fill-finish systems.
Responsibilities- Author and execute IQ/OQ/PQ protocols and validation reports.
- Support commissioning, startup, and qualification activities.
- Write and investigate CQV-related deviations and support CAPA.
- Support qualification of bioreactors, vessels, fill-finish lines, transfer panels, CIP/SIP systems, and process utilities.
- Support risk assessments, change controls, and project documentation.
- Collaborate with Engineering, Manufacturing, Quality, and Validation teams.
- Support audit and regulatory inspection readiness.
Requirements- Bachelor's degree in Engineering, Life Sciences, Biotechnology, or a related field.
- 10+ years of CQV, Validation, Quality, or Engineering experience in pharmaceutical, biotech, or life sciences environments.
- Experience authoring and executing IQ/OQ/PQ protocols.
- Experience with deviations, investigations, and CAPA in GMP environments.
- Knowledge of FDA, cGMP, and validation requirements.
- Strong technical writing and communication skills.
- Ability to work onsite in Brooklyn Park, MN.