Minneapolis, MN, USA $110 - $140 per hour Posted 1 week agoAbout the Role A 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 changesLead computer system validation activities for MES, LIMS, and shop-floor data systemsMaintain validation master plans, risk assessments and traceability across the site portfolioSupport change control, deviation investigations and CAPAs related to validated systemsPrepare validation documentation for FDA, MDSAP and notified body auditsCoach manufacturing engineers and technicians on validation good practice and documentation standardsRequirements 6+ years of validation engineering in medical device, pharmaceutical or biologics manufacturingHands-on experience authoring and executing IQ, OQ, PQ, PPQ and CSV (Part 11) protocolsStrong working knowledge of ISO 13485, 21 CFR 820 and risk-based validation per GAMP 5Comfort working in cleanroom environments and with regulated production equipment (moulding, packaging, sterilisation)Excellent technical writing skills - protocols, reports and traceability matricesDegree in Mechanical, Biomedical, Chemical or Manufacturing Engineering#J-18808-Ljbffr