CQV Specialist

Seeking 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.

• 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.

• 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.