Validation Engineer; CSV/IQ-OQ-PQ
Job in
Minneapolis, Hennepin County, Minnesota, 55400, USA
Listed on 2026-06-15
Listing for:
The Sentio Group
Full Time
position Listed on 2026-06-15
Job specializations:
-
Engineering
Quality Engineering, Validation Engineer, Biomedical Engineer, Pharma Engineer
Job Description & How to Apply Below
Minneapolis, MN, USA $110 - $140 per hour Posted 1 week ago
About the RoleA leading Class III medical device OEM is expanding US manufacturing capacity and needs a Validation Engineer who can own equipment, process and computer system validation for a regulated cleanroom environment. You will write protocols, execute IQ/OQ/PQ, and partner with Quality and Manufacturing Engineering to keep the validation portfolio inspection-ready against ISO 13485 and 21 CFR 820.
Responsibilities- Author and execute IQ / OQ / PQ protocols for new equipment installations and process changes
- Lead computer system validation activities for MES, LIMS, and shop-floor data systems
- Maintain validation master plans, risk assessments and traceability across the site portfolio
- Support change control, deviation investigations and CAPAs related to validated systems
- Prepare validation documentation for FDA, MDSAP and notified body audits
- Coach manufacturing engineers and technicians on validation good practice and documentation standards
- 6+ years of validation engineering in medical device, pharmaceutical or biologics manufacturing
- Hands-on experience authoring and executing IQ, OQ, PQ, PPQ and CSV (Part 11) protocols
- Strong working knowledge of ISO 13485, 21 CFR 820 and risk-based validation per GAMP 5
- Comfort working in cleanroom environments and with regulated production equipment (moulding, packaging, sterilisation)
- Excellent technical writing skills - protocols, reports and traceability matrices
- Degree in Mechanical, Biomedical, Chemical or Manufacturing Engineering
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