MSAT Expert: Contamination Control (Sterile)

Lonza; Stein; Vor Ort; Vertraulich; Vollzeit

Benefits dieser Stelle

Agile career culture

Inclusive workplace

Competitive compensation

Zusammenfassung

Lonza in Stein, AG, is seeking a senior specialist to own the Contamination Control Strategy for a state-of-the-art sterile manufacturing facility. You will lead APS/Media Fills, EMPQ, Smoke Studies, Cleaning Validation and risk assessments to ensure inspection readiness and regulatory compliance while supporting lifecycle programs across the site.

This fully site-based role emphasizes real-time collaboration, strategic technical leadership, and driving continuous improvement in sterility

Qualifikationen

• Experience in aseptic Drug Product manufacturing, including Fill & Finish.
• Expertise in Cleaning Validation or Contamination Control Strategy (CCS) within sterile manufacturing.
• Degree in Engineering, Life Sciences, or Pharmaceutical Sciences, with fluent English.

Aufgaben

• Act as SME for Sterility Assurance, Contamination Control and Cleaning Validation.
• Lead CCS implementation and risk assessments across site.
• Support lifecycle strategy and validation activities (APS/Media Fills, EMPQ, Smoke Studies).
• Develop and sustain Cleaning Validation protocols and strategies.
• Drive investigations, deviations, CAPAs and continuous improvement with cross-functional partners.

Kenntnisse

Sterility Assurance

Contamination Control

Cleaning Validation

APS/Media Fills

Risk Assessments

Cross-functional Collaboration

Regulatory Inspections

Ausbildung

Engineering / Life Sciences / Pharmaceutical Sciences degree

Jobbeschreibung

Lonza in Stein, AG, is seeking a senior specialist to own the Contamination Control Strategy for a state-of-the-art sterile manufacturing facility. You will lead APS/Media Fills, EMPQ, Smoke Studies, Cleaning Validation and risk assessments to ensure inspection readiness and regulatory compliance while supporting lifecycle programs across the site.

This fully site-based role emphasizes real-time collaboration, strategic technical leadership, and driving continuous improvement in sterility