KC
CQV Specialist
External job listingat Katalyst CRO
Tasks Author, review, and execute #IQ/OQ/PQ protocols and validation reports. Develop and execute qualification documentation in compliance with #GMP requirements. Support commissioning,...
External source - not verified2 weeks agoOpen until: Jan 10, 2027
Salary
Not provided
Location
Minneapolis, United States
Employment type
Full time
Workplace
Not provided
CQV Specialist
Minneapolis, United States
Job description
Tasks
- Author, review, and execute #IQ/OQ/PQ protocols and validation reports.
- Develop and execute qualification documentation in compliance with #GMP requirements.
- Support commissioning, startup, and qualification of manufacturing equipment and systems.
- Write, investigate, and resolve #CQV-related deviations.
- Support root cause investigations and #CAPA implementation.
Requirements
- 10+ years of #CQV, Validation, Quality, or Engineering experience in Pharma/Biotech/Life Sciences.
- Hands-on experience authoring and executing #IQ/OQ/PQ protocols.
- Strong #GMP-regulated environment and deviation management experience.
- Working knowledge of #FDA, #cGMP, and validation requirements.
- Experience with manufacturing equipment and process systems.
- Bachelor’s degree in Engineering, Life Sciences, Biotechnology, or related technical discipline.
How to apply
- Send your resume by email.
- Apply through the link.
Location
- Minneapolis, MN