Validation Engineer
$90,200–$124,000 year
On-site · Buffalo, Illinois, United States
Job Summary
Validate and oversee process validation activities for medical device manufacturing at Flex, drafting and executing validation plans, IQ/OQ/TMV/PQ protocols, and support for software or facilities validations. Interface with customers on technical/quality issues, manage audits as SME for the area, ensure compliance with regulatory requirements, and drive improvement of quality system processes through validation deliverables and change controls. Requires hands-on experience with qualification activities, risk management, traceability matrices, and summaries, plus the ability to analyze problems, propose improvements, and work independently within manufacturing environments.
Required Qualifications
- Bachelor’s (in engineering, sciences or related field)
- 6 years of validation experience
- Previous process and product validation experience
- 4 years of medical device, pharmaceutical or biotechnology industry with understanding of CFR Part 820, Part 11, ISO 13485, Annex 11, ISO9001, GAMP standards
- 4 years of injection molding experience
- Experience in generating, review and approval of validation deliverables, statistical analysis, risk management, incident and change management
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