Senior Specialist, Validation Engineer II

Role: Senior Specialist, Validation Engineer II, supporting manufacturing and laboratory equipment validation at multi-use biopharma sites. Responsibilities: develop validation/qualification deliverables (validation plans, protocols, reports), execute lifecycle validation activities, manage requalification and change control processes, and support equipment, facilities, utilities, and sterilization qualification aligned with cGMP standards. Ensure regulatory compliance, participate in audits, and contribute to inspection readiness. Requirements: Bachelor’s in Chemical/Mechanical Engineering or related field; 3+ years of experience with process equipment, automation, and laboratory instrumentation in FDA-regulated biologics or cell therapy manufacturing; 2+ years’ experience in qualification activities. Knowledge of regulatory guidelines (FDA, EMA, ICH Q7/Q8/Q9), validation principles, and GMP compliance is essential. Preferred: familiarity with GAMP, lean/six sigma methodologies, and experience with automated manufacturing systems. HighValue: biologics/cell therapy manufacturing, equipment and utility qualification, validation lifecycle management, GxP compliance, and regulatory audit support. WorkSetup: not specified; role may involve interaction across manufacturing and validation teams.