Senior Validation Engineer
Core
Planning, scheduling, executing, and leading validation projects for manufacturing processes, equipment, utilities, and sterile product cycles.
Role type
Senior Validation Engineer (Pharmaceutical Manufacturing)
Builds
Validated state of manufacturing processes, equipment, and facilities for sterile pharmaceutical products.
Domain
Pharmaceutical manufacturing / Sterile processing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Validation lifecycle management, protocol development, risk assessment, gap analysis, deviation investigation, process capability analysis, aseptic gowning techniques, regulatory compliance knowledge, cross-functional project leadership
Preferred skills
Sterile product and medical device experience, regulatory audit support, AI tool utilization for problem solving, mentoring capabilities
Technologies
FRS, URS, FAT, SAT, DQ, IQ, OQ, PQ, SAP (implied by APQR context), AI tools (ChatGPT, Copilot)
Responsibilities
Develop validation master plans, SOPs, and protocols; execute qualification activities for equipment and processes; support corrective actions and deviation resolution; conduct process capability analysis; prepare Annual Product Quality Reports; lead projects to reduce process risk.
Seniority
Senior, hands-on IC
