Summary from listing
Emergent BioSolutions is hiring a Senior Engineer, Validation to ensure cGMP regulatory compliance through validation plans, protocols, and oversight of commissioning, qualification, computer systems, maintenance, risk management, and laboratory systems. The role independently manages capital, client, and overhead projects; provides subject-matter expertise and technical leadership; supports engineering, quality, manufacturing, and technology; and leads investigations, CAPAs, deviations, regulatory inspections, and process troubleshooting. Candidates need a BS in engineering, chemistry, microbiology, or a related field, or at least eight years of related industrial experience in system qualification or validation, along with knowledge of GxP, ISPE, EU, CFR 210/211, and Part 11, and experience with GMP-related systems.
