Senior CQV/CSV Engineer
Job in
Maple Grove, Hennepin County, Minnesota, 55311, USA
Listed on 2026-02-28
Listing for:
Staftonic LLC
Full Time
position Listed on 2026-02-28
Job specializations:
-
Engineering
Validation Engineer, Quality Engineering, Biomedical Engineer, Pharma Engineer
Job Description & How to Apply Below
- Lead lifecycle Commissioning and Qualification (CQV) activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Author, review, and execute validation protocols and reports for multi-use and single-use manufacturing systems.
- Develop and maintain key validation documents, including:
- Risk Assessments (FMEA / Risk-Based Validation)
- Traceability Matrices (RTM)
- Validation Summary Reports (VSR)
- Deviation Reports and CAPAs
- Collaborate with automation and engineering teams to ensure synchronization between physical equipment and automated control systems.
- Support validation of integrated GMP systems, including automation platforms and electronic documentation systems.
- Apply risk-based validation approaches in alignment with ASTM E2500 principles.
- Ensure compliance with 21 CFR Part 11, Data Integrity (ALCOA+), GAMP 5, and current industry best practices.
- Drive validation activities independently in a fast-paced manufacturing environment.
- Minimum 6+ years of CQV and/or CSV experience within the life sciences industry.
- Strong hands-on experience executing IQ/OQ/PQ for GMP-regulated manufacturing equipment.
- Proven experience validating biologics manufacturing systems such as:
- Bioreactors
- TFF (Tangential Flow Filtration) systems
- Chromatography systems
- CIP/SIP systems
- Filtration skids
- Experience with deviation management and regulatory audit readiness.
- Strong technical writing and documentation skills.
- Ability to work independently with minimal oversight.
Position Requirements
10+ Years
work experience
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