MSAT Expert – Contamination Control
lonza · Stein
Job description
About the role
You will shape and drive the Contamination Control Strategy for a state‑of‑the‑art sterile manufacturing facility in Stein, supporting the implementation, maintenance and continuous improvement of sterility assurance and cleaning validation programs. This is a fully site‑based position that requires close, real‑time collaboration to ensure inspection readiness and operational excellence.
Key responsibilities
- Lead the facility‑wide Contamination Control Strategy, including risk assessments, cross‑contamination prevention, and validation activities such as APS/Media Fills, EMPQ, and Smoke Studies.
- Develop, optimize and sustain cleaning validation protocols and lifecycle programs, closing compliance gaps and strengthening process robustness.
- Drive complex investigations, deviations, CAPAs and continuous‑improvement initiatives while supporting start‑up, project delivery and regulatory inspections.
Required profile
- Hands‑on experience in aseptic drug product manufacturing, especially Fill & Finish operations for vials or syringes.
- Proven expertise in either Cleaning Validation or Contamination Control Strategy within sterile drug product manufacturing.
- Degree in Engineering, Life Sciences, Pharmaceutical Sciences or related discipline and fluent English communication skills.
Required skills
- Aseptic processing principles and sterile manufacturing operations.
- Cleaning validation, risk‑based assessments, and contamination control techniques.
- Understanding of cleanroom classifications, material flows, HVAC concepts, and regulatory inspection support.
What we offer
- Agile career development and a dynamic, inclusive work culture.
- Competitive salary with comprehensive lifestyle, family and leisure benefits.
- Relocation assistance for eligible candidates and their families.
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Published 1 day ago
Expires 1 month from now
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lonza
Stein
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