Validation Engineer III
$115,500–$128,000 year
On-site · Dunkirk, New York, United States
Job Summary
Coordinate validation activities across equipment, utilities, facilities, processes, and automation within an FDA-regulated biopharmaceutical environment. Generate and execute validation protocols (IQ/OQ/PQ/CV/PV) for site equipment andLaboratory/production systems; author and review SOPs, protocols, reports, and validation master plans; maintain GMP system inventories and requalification schedules. Lead risk assessments, plan validation efforts by risk, collaborate with clients, CMOs, and vendors, and oversee contractor activities. Chair audits and regulatory inspections for Validation; serve as subject matter expert in IQ/OQ/PQ; manage multiple projects, timelines, and end-user training to support GMP operations. Requires strong technical writing, project management, and cross-functional collaboration across QA, manufacturing, engineering, and external partners.
Required Qualifications
- Bachelor’s degree in science or related discipline
- 5+ years of relevant validation or GMP-regulated industry experience
- Experience with facility commissioning and validation of equipment and facilities
- Strong knowledge of validation principles including IQ/OQ/PQ related to equipment and facilities
- Good interpersonal and communication skills
- Working knowledge of GMPs, OSHA compliance, 21 CFR 11, and cleanrooms
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