Operation Cleaning BPE
Core
Overseeing and optimizing cleaning operations in a GMP-compliant manufacturing environment for a mammalian asset in its startup phase.
Role type
Senior Manufacturing Operations Cleaning Specialist (Biopharma)
Builds
GMP-compliant cleaning processes and documentation for mammalian bioprocessing assets
Domain
Life Sciences / Biopharmaceutical Manufacturing
Required skills
GMP compliance, cleaning process optimization, Lean Six Sigma, risk assessment, root cause analysis, team leadership, change management, CAPA management, audit support
Preferred skills
Startup phase experience, mammalian cell culture knowledge, MSAT collaboration
Technologies
MES/DeltaV, GMP documentation systems
Responsibilities
Guide and support the team in implementing and optimizing cleaning processes; Ensure timely, high-quality preparation, creation, optimization, control, and review of manufacturing cleaning-related documents; Act as the Manufacturing Operations representative and subject matter expert during internal and external audits; Collaborate with MSAT and QA cleaning validation group to improve cleaning process robustness; Supervise GMP production and provide organizational oversight to ensure cleaning activities are performed correctly and timely; Lead or participate in root cause analysis, CAPA definition, and change implementation processes.
Seniority
Senior, hands-on IC with team leadership