Process Hygiene Manager
Core
Provide site-wide leadership and governance for the Process Hygiene program across Biologics Manufacturing, covering Central Services, Cell Culture and Purification, ensuring compliance with cGMP and driving risk reduction.
Role type
Senior Process Hygiene Manager (Biologics Manufacturing)
Builds
Biologics facility cleaning and disinfection programs, contamination-control systems, and microbial/environmental monitoring integration.
Domain
Biologics/pharmaceutical manufacturing, aseptic processing, contamination control
Required skills
cGMP compliance, contamination control, aseptic processing, FMEA, risk assessment, CAPA, change control, regulatory inspection readiness, data trending, root-cause analysis, team leadership, strategic planning
Preferred skills
Statistical tools, environmental/process-monitoring data analysis
Technologies
None explicitly stated
Responsibilities
Develop and maintain site Process Hygiene strategy and governance model; lead alignment with global network standards; oversee facility cleaning and disinfection strategy; manage contamination-control priorities and risk assessments; represent Process Hygiene during regulatory inspections; lead cross-functional initiatives and develop the Process Hygiene team.
Seniority
Senior, hands-on IC with leadership responsibilities