About this opportunity
The Sentio Group lists this Chief Information Officer (CIO) & Chief Digital Officer (CDO) opportunity in minneapolis, Minnesota. Review the employer’s description below for duties, qualifications and application requirements.
Job description
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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Worksite address
minneapolis, MN, 55400, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.