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 Contamination Control and Cleaning Validation
Builds
Sterile drug product manufacturing operations and regulatory-compliant facilities
Domain
Pharmaceutical manufacturing / Sterile processing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Aseptic manufacturing expertise, Contamination Control Strategy (CCS) implementation, Cleaning Validation lifecycle management, Risk-based assessment, Environmental Monitoring Performance Qualification (EMPQ), Aseptic Process Simulations (APS/Media Fills), Cleanroom classification knowledge, HVAC concepts, Regulatory inspection support
Preferred skills
Experience with Fill & Finish operations, Health authority interaction (FDA, Swissmedic)
Technologies
HVAC systems, Cleanroom classification standards, Validation protocols
Responsibilities
Drive risk assessments and cross-contamination prevention measures, Execute sterility assurance programs including APS and EMPQ, Develop and optimize Cleaning Validation protocols, Lead complex investigations and CAPAs, Support facility start-up and regulatory inspections
Seniority
Senior, hands-on IC
