Sterility Assurance Manager
Core
Accountable for sterility assurance across the site, defining and maintaining contamination control strategies, overseeing environmental monitoring and media fill programs, and leading aseptic process investigations.
Role type
Sterility Assurance Manager
Builds
Sterile injectable and oral solid dose drug products
Domain
Pharmaceutical manufacturing (sterile)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Contamination control strategy definition, Environmental monitoring program oversight, Media fill program management, Aseptic process simulation expertise, Risk assessment leadership, Regulatory compliance (FDA/EU Annex 1), Root cause analysis, Audit execution, Capital project leadership
Preferred skills
Microbiology laboratory experience, Sterile manufacturing facility experience, Validation experience, Technical writing, Influencing
Technologies
GMP, Annex 1, Media Fill, Environmental Monitoring
Responsibilities
Define and maintain contamination control strategy, Oversee environmental monitoring (EM) program, Lead aseptic behavior training and oversight, Investigate sterility assurance issues, Review major deviations and change proposals, Represent site on Sterile Working Group, Audit sterile sites and suppliers
Seniority
Senior, hands-on IC with leadership responsibilities
