MSAT Expert - Contamination Control

MSAT Expert - Contamination Control
Lonza
Stein, Switzerland
In 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.
What you will do:
Act 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.
Support 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.
Support 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.
Develop, 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.
Drive 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.
What we are looking for:
Hands-on experience in aseptic Drug Product manufacturing, including Fill & Finish operations for vials and/or syringes, with a strong understanding of sterile processing principles.
Proven expertise in either Cleaning Validation or Contamination Control Strategy (CCS) within sterile drug product manufacturing.
Solid understanding of cleanroom classifications, material flows, HVAC concepts and contamination control principles, combined with the ability to perform and document risk-based assessments.
Degree 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.
Agile, 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.
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