Chief Information Officer (CIO) & Chief Digital Officer (CDO)

Minneapolis, MN, USA $110 - $140 per hour Posted 1 week ago

About 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 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

Requirements

• 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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