Validation Engineer/Quality Systems Engineer
$90,000–$100,000 year
On-site · Vernon Hills, Illinois, United States
Job Summary
Validation Engineer/Quality Systems Engineer responsible for owning the full validation lifecycle, including writing and executing validation protocols for manufacturing equipment, processes, and systems; managing the calibration system and equipment database; analyzing validation data, addressing nonconformities, and tracking CAPA; supporting design controls, change control, post-market surveillance, and providing FDA compliance guidance. Requires knowledge of ISO 13485, ISO 14971, 21 CFR Part 820, EU-MDR, and experience with process and test method validations in FDA-regulated environments; background in medical device or pharmaceutical manufacturing; Blow-Fill-Seal experience is a plus.
Required Qualifications
- Experience with process and test method validations in an FDA-regulated industry
- Knowledge of ISO 13485, ISO 14971, 21 CFR Part 820, and EU-MDR
- Background in medical device or pharmaceutical manufacturing
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