Recognized expert across process design / QbD, PPQ, CPV, revalidation, cleaning, sterilization and aseptic process simulation, with deep command of global GMP expectations, QRM, statistics and validation implications of advanced analytics/modeling across internal sites and external partners. Partner with Manufacturing, PharmSci, CMC, Tech Transfer, Engineering/CQV, Quality, Regulatory Affairs and Data & Analytics to embed validation requirements into launches, transfers, startups, process changes and lifecycle management.