Sterility Assurance Manager
Core
Senior QA Sterility Assurance SME leading aseptic practices, contamination control, and environmental monitoring for clinical and commercial biopharmaceutical manufacturing.
Role type
Senior IC Sterility Assurance Manager
Builds
High-value biopharmaceutical products
Domain
Biopharmaceutical manufacturing / Sterility Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Sterility Assurance expertise, aseptic processing, contamination control, environmental monitoring, aseptic process simulation, sterilization and filtration, GMP compliance, technical writing, risk-based approach
Preferred skills
Contamination Control Strategy (CCS) development, Aseptic Improvement Plan leadership, audit representation, cross-functional collaboration
Technologies
GMP, CCS, Aseptic Process Simulation, Environmental Monitoring, Sterilization, Filtration
Responsibilities
Define and maintain processes supporting product sterility, develop strategies to strengthen aseptic manufacturing standards, escalate major Sterility Assurance events, lead execution of Contamination Control Strategy and Aseptic Improvement Plan, review and approve aseptic process simulation strategies, author environmental qualification protocols and reports, conduct shop-floor inspections and audits, participate in customer and regulatory audits, support investigations involving product contamination, develop and deliver training on Sterility Assurance topics
Seniority
Senior, hands-on IC