Validation Engineer
On-site · Palm Coast, Florida, United States
Job Summary
Plan, execute, and document validation activities across the product and process lifecycle, including VMP, IQ, OQ, and PQ; develop, review, and approve validation master plans, protocols, and reports; partner with Manufacturing, Engineering, Quality, Regulatory, and Supply Chain to support new product introductions, capacity expansions, equipment transfers, and site expansion; ensure validation practices meet FDA/ISO and customer requirements; maintain lifecycle compliance through change control, revalidation, periodic reviews, deviations, CAPAs, and nonconformances; participate in internal, customer, and regulatory audits and inspections; provide technical guidance to site teams and contribute to continuous improvement; travel internationally up to 50% as required.
Required Qualifications
- Bachelor’s degree in Engineering, Life Sciences, or related technical discipline (Mechanical, Chemical, Biomedical, Industrial Engineering)
- 3–7 years of experience in equipment, process, or system validation in a regulated manufacturing environment (medical device, pharmaceutical, biotechnology, or similar)
- Experience creating and executing VMP, IQ, OQ, and PQ activities
- Ability to collaborate with Quality, Engineering, Manufacturing, Regulatory, and other cross-functional teams
- Willingness to travel internationally up to 50%
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