h3MSAT Expert - Contamination Control /h3pLonza /ppStein, Switzerland /ppIn this role, you will shape and drive the Contamination Control Strategy (CCS) for a state-of-the-art sterile manufacturing facility, leading key initiatives such as APS/Media Fills, EMPQ, Smoke Studies, Cleaning Validation and associated risk assessments to ensure inspection readiness and operational excellence. /ph3What you will do: /h3ulliAct as Subject Matter Expert for Sterility Assurance, Contamination Control and Cleaning Validation, providing strategic technical leadership to support compliant, efficient and inspection-ready sterile manufacturing operations. /liliSupport the implementation, maintenance and continuous improvement of the facility-wide Contamination Control Strategy (CCS), driving risk assessments, cross-contamination prevention measures and robust contamination control programs across the site. /liliSupport the lifecycle strategy and execution of key sterility assurance programs, including Aseptic Process Simulations (APS/Media Fills), Environmental Monitoring Performance Qualification (EM PQ), Smoke Studies, EMPQ and associated validation activities. /liliDevelop, optimize and sustain Cleaning Validation protocols, strategies and lifecycle programs, closing compliance gaps, strengthening process robustness and ensuring effective validation of equipment, facilities and manufacturing processes. /liliDrive complex investigations, deviations, CAPAs and continuous improvement initiatives while partnering across functions to support facility start-up, project delivery, regulatory inspections and the successful growth of a landmark greenfield sterile manufacturing facility. /li /ulh3What we are looking for: /h3ulliHands-on experience in aseptic Drug Product manufacturing, including Fill Finish operations for vials and/or syringes, with a strong understanding of sterile processing principles. /liliProven expertise in either Cleaning Validation or Contamination Control Strategy (CCS) within sterile drug product manufacturing. /liliSolid understanding of cleanroom classifications, material flows, HVAC concepts and contamination control principles, combined with the ability to perform and document risk-based assessments. /liliDegree in Engineering, Life Sciences, Pharmaceutical Sciences or a related discipline, with fluent English communication skills and the ability to collaborate effectively across diverse technical and operational stakeholders. /liliAgile, proactive and solutions-oriented mindset, with the ability to thrive in a fast-paced, dynamic environment and drive alignment across multiple functions; experience supporting regulatory inspections and health authority interactions (e.g. FDA, Swissmedic) is a plus. /li /ul #J-18808-Ljbffr
