Sterility Assurance Lead
Core
Own and drive the site's sterility assurance strategy, ensuring compliance with global regulatory requirements and serving as the SME for contamination control, aseptic processing, and sterilization validation.
Role type
Senior IC sterility assurance lead (pharmaceutical manufacturing)
Builds
Sterile pharmaceutical products and biologics
Domain
Pharmaceutical manufacturing / Sterile processing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Contamination control strategy (CCS) design, Aseptic processing expertise, Sterilization validation (moist/dry heat, filtration), Environmental monitoring program management, Risk assessment (FMEA, HACCP), GMP compliance, Audit/inspection support, CAPA leadership, Technical mentorship
Preferred skills
Experience with isolators/RABS, HVAC qualification, Cross-functional stakeholder influence, Continuous improvement initiatives
Technologies
EU GMP Annex 1, FDA/EMA/PIC/S regulations, FMEA, HACCP, Isolators, RABS, HVAC systems
Responsibilities
Lead the Sterility Assurance Program (SAP) and Contamination Control Strategy (CCS), Oversee environmental monitoring and cleanroom qualification, Review sterilization validations and lead media fill programs, Drive contamination risk assessments and investigations, Act as SME during audits and inspections, Provide training and mentorship in sterility assurance best practices
Seniority
Senior, hands-on IC with leadership capabilities