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MSAT Expert – Contamination Control

lonza · Stein

New
Senior 🇬🇧 English
aseptic drug product manufacturing cleaning validation contamination control strategy risk assessments cleanroom classifications HVAC concepts APS/Media fills environmental monitoring performance qualification smoke studies

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.

Questions fréquentes

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Source : ats:workday

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Published 1 day ago

Expires 1 month from now

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lonza

Stein