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MSAT Expert- Contamination Control 80-100%

Schweiz💼 Full-time🗓 2026-09-26 → 2026-09-27

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

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