Manager, Aseptic Process Excellence
Core
Leads site-wide aseptic training, personnel qualification, and contamination control programs to minimize human error and mitigate risk in regulated sterile manufacturing environments.
Role type
Senior Manager, Aseptic Process Excellence
Builds
Sterile manufacturing operations, aseptic training curricula, and qualification programs
Domain
Pharmaceutical manufacturing / Aseptic processing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (sterile manufacturing operations)
Required skills
Strategic leadership, aseptic technique expertise, contamination control, training program design, performance management, data-driven analysis, regulatory compliance, cross-functional partnership, budget management, team development
Preferred skills
Experience with media fill simulations, airflow visualization studies, CAPA leadership, regulatory inspection support, cleanroom management systems
Technologies
Gowning systems, environmental monitoring equipment, media fill simulation tools, airflow visualization tools
Responsibilities
Lead the Aseptic Training and Mentorship Program; Direct planning and management of Aseptic Mentor resources; Establish departmental goals and KPIs; Serve as site subject matter expert for aseptic behavior; Lead investigations and CAPAs for contamination events; Provide leadership during regulatory inspections; Manage departmental operational budgets; Lead and develop a team overseeing aseptic operations across four shifts.
Seniority
Manager, strategic leadership & team oversight
