MSAT Expert- Contamination Control 80-100%
Core
Lead the Contamination Control Strategy (CCS) and sterility assurance programs for a greenfield sterile manufacturing facility.
Role type
Senior Subject Matter Expert in Sterility Assurance and Contamination Control
Builds
Sterile drug product manufacturing operations and compliant manufacturing sites
Domain
Pharmaceutical manufacturing / Sterile processing
Required skills
Aseptic manufacturing expertise, Contamination Control Strategy (CCS) development, Cleaning Validation lifecycle management, Risk-based assessment, Cleanroom classification knowledge, HVAC concepts, Regulatory inspection support
Preferred skills
Experience with APS/Media Fills, EMPQ, Smoke Studies, FDA/Swissmedic interactions
Technologies
None explicitly listed
Responsibilities
Drive implementation and maintenance of facility-wide Contamination Control Strategy (CCS), Execute sterility assurance programs including Aseptic Process Simulations (APS) and Environmental Monitoring Performance Qualification (EM PQ), Develop and optimize Cleaning Validation protocols, Lead complex investigations, deviations, and CAPAs, Partner across functions for facility start-up and regulatory readiness
Seniority
Senior, hands-on IC