Senior Validation or Validation SME for new filling line project (Osaka Plant)
Core
Develop and execute validation strategies for a new filling line project involving liquid/powder filling, sterilization, and cleaning equipment at the Osaka plant.
Role type
Senior Validation SME (Manufacturing/Engineering)
Builds
Validated filling lines and associated process equipment for pharmaceutical production
Domain
Pharmaceutical manufacturing / Biotechnology / GMP compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Validation strategy development, protocol creation, risk analysis (FMEA), cross-functional team leadership, regulatory compliance interpretation (GMP, FDA, ISO), troubleshooting, project planning
Preferred skills
Experience with isolators and aseptic filling processes, FDA interaction experience, engineering or technical service department experience
Technologies
Validation test equipment (loggers), GAMP5, 21CFR Part 11, cGXP
Responsibilities
Create and execute validation strategies for filling/sterilization lines, coordinate cross-functional teams, conduct risk analysis and troubleshooting, support internal/external audits, manage validation documentation for regulatory submission
Seniority
Senior, hands-on IC
