Sterility Assurance Lead - Contamination Control Expert

Lonza Group Ltd.; Stein (AR); Vor Ort; CHF 120.000 - 180.000; Vollzeit

Benefits dieser Stelle

Agile career culture

Inclusive workplace

Competitive compensation programs

Lifestyle, family & leisure benefits

Zusammenfassung

Lonza Group Ltd. seeks a senior specialist to shape and drive the Contamination Control Strategy for a state‑of‑the‑art sterile manufacturing facility in Stein, Switzerland.

You will lead initiatives like APS/Media Fills, EMPQ, Smoke Studies, and Cleaning Validation while ensuring regulatory compliance and robust manufacturing performance throughout the product lifecycle. This fully site‑based role emphasizes real‑time collaboration and technical precision to manufacture medicines to the highest

Qualifikationen

• Experience in aseptic Drug Product manufacturing, including Fill & Finish operations.

Aufgaben

• Act as SME for Sterility Assurance, Contamination Control and Cleaning Validation.
• Support CCS implementation, risk assessments, cross‑contamination prevention measures and robust control programs.
• Lifecycle strategy and execution of key sterility assurance programs (APS/Media Fills, EM PQ, Smoke Studies, EMPQ).
• Develop, optimize and sustain Cleaning Validation protocols and lifecycle programs.
• Drive investigations, deviations, CAPAs and continuous improvement with cross‑functional partners.

Kenntnisse

Aseptic manufacturing

Sterility assurance

Contamination control

Cleaning validation

Risk assessment

Ausbildung

Engineering/Life sciences degree

Tools

APS/Media Fills

Environmental Monitoring PQ

Cleanroom concepts

Jobbeschreibung

Lonza Group Ltd. seeks a senior specialist to shape and drive the Contamination Control Strategy for a state‑of‑the‑art sterile manufacturing facility in Stein, Switzerland.

You will lead initiatives like APS/Media Fills, EMPQ, Smoke Studies, and Cleaning Validation while ensuring regulatory compliance and robust manufacturing performance throughout the product lifecycle. This fully site‑based role emphasizes real‑time collaboration and technical precision to manufacture medicines to the highest