Engineer II, Validation
Thermo Fisher Scientific · Middletown, VA
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Role summary
Thermo Fisher Scientific seeks a Validation Engineer to support qualification and validation activities for clinical diagnostic reagent manufacturing in a cGMP, FDA-regulated environment. The role involves developing validation protocols, executing testing, analyzing results, and maintaining compliance with regulatory requirements.
What they're looking for
- Bachelor's degree in Engineering, Life Sciences, Chemistry, or related scientific discipline
- 2+ years validation, qualification, engineering, or quality experience in regulated environment
- Experience authoring, reviewing, and executing IQ, OQ, and/or PQ protocols
- Strong technical writing and documentation skills
- Strong analytical and problem-solving capabilities
- Ability to interpret technical requirements and evaluate results against acceptance criteria
What you'll be doing
- Develop, implement, and maintain Validation Master Plans for equipment, systems, utilities, and processes
- Author and execute validation protocols including IQ, OQ, and PQ documentation
- Analyze validation data and document results to verify equipment and processes meet requirements
- Participate in periodic validation reviews, gap assessments, and lifecycle evaluations
- Collaborate cross-functionally with Engineering, Quality, Manufacturing on validation activities and change controls
Privacy & handoff
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