【今市】生産技術（MSAT Execution）
Core
Subject matter expert validating, optimizing, and maintaining robust manufacturing and cleaning processes to ensure consistent production of safe, effective, and cost-efficient pharmaceutical products.
Role type
Senior Manufacturing and Cleaning Process Validation Engineer (MSAT)
Builds
Validated manufacturing and cleaning processes for specialty medicines and vaccines
Domain
Pharmaceutical manufacturing / Biopharma
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP/GDP compliance, Process validation, Cleaning validation, Root cause analysis, Technical transfers, Data analysis, Risk management, Project management, Scientific writing, Change control
Preferred skills
Scale-up, Technology transfers, QbD, Process capability assessment, Contamination control, Product Control Strategy
Technologies
GxP Regulations, Lean Management, Data Integrity
Responsibilities
Plan and execute process and cleaning validation activities; Monitor critical process parameters for Continued Process Verification; Analyze process data to identify optimization opportunities; Support technical transfers and equipment qualification; Lead root cause investigations and change impact assessments; Author and maintain technical protocols and reports.
Seniority
Senior, hands-on IC
