Contamination Control and Sterility Assurance Sr. Specialist
Core
Drive contamination control strategies and sterility assurance programmes to ensure product quality, patient safety, and regulatory compliance in life sciences manufacturing and laboratory operations.
Role type
Senior Individual Contributor (IC) Contamination Control and Sterility Assurance Specialist
Builds
Sterility assurance programmes, environmental monitoring systems, cleanroom qualifications, and CAPA implementations for pharmaceutical, medical device, and biotechnology products.
Domain
Life Sciences / Biotechnology / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Contamination control strategy development, Environmental monitoring programme management, Cleanroom qualification and requalification, Microbiological lifecycle management, Root cause analysis, CAPA implementation, Quality Risk Management (FMEA), Data analysis and trending, Knowledge of ISO 14644, ISO 11137, ISO 11737, EN 17141, Deviation management, Change control
Preferred skills
Endotoxin, bioburden, sterility, and particulate testing, Sterilisation validation support, Subject matter expert for regulatory and customer audits
Technologies
ISO 14644, ISO 11137, ISO 11737, EN 17141
Responsibilities
Develop and maintain contamination control strategies and sterility assurance programmes; Lead microbiological lifecycle and qualification activities; Provide oversight of environmental monitoring programmes; Lead investigations into contamination events and deviations; Collaborate on cross-functional quality risk management and continuous improvement initiatives
Seniority
Senior, hands-on IC