MSAT Contamination Control Lead for Sterile Manufacturing

1000scholars; Stein (AR); On-site; CHF 140,000 - 190,000; Full time

Job summary

Lonza in Stein, Switzerland seeks an MSAT Expert to lead Contamination Control Strategy for a state-of-the-art sterile manufacturing facility. You will drive APS/Media Fills, EM PQ, Smoke Studies and Cleaning Validation to ensure inspection readiness and operational excellence.

You will act as SME for sterile processing, support CCS deployment, and guide risk assessments while collaborating across functions and supporting regulatory inspections with a proactive, agile mindset.

Qualifications

• Hands-on experience in aseptic Drug Product manufacturing, including Fill & Finish for vials and/or syringes.
• Proven expertise in 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.
• Degree in Engineering, Life Sciences, Pharmaceutical Sciences or related discipline; fluent English.
• Agile, proactive mindset with ability to work across functions; regulatory inspections experience a plus.

Responsibilities

• Act as Subject Matter Expert for Sterility Assurance, Contamination Control and Cleaning Validation.
• Support CCS implementation and risk assessments across site.
• Lead lifecycle programs including APS/Media Fills, Environmental Monitoring Performance Qualification (EM PQ), Smoke Studies, EMPQ.
• Develop and sustain Cleaning Validation protocols and lifecycle programs.
• Drive investigations, deviations, CAPAs and continuous improvement; support inspections and startup.

Skills

Sterility Assurance

Contamination Control

Cleaning Validation

Risk Assessments

Cross-contamination Prevention

Environmental Monitoring

Aseptic Processing

APS/Media Fills

EM PQ

CAPA & Investigations

Regulatory Inspections

Interdisciplinary Collaboration

Education

Engineering

Life Sciences

Pharmaceutical Sciences

Job description

Lonza in Stein, Switzerland seeks an MSAT Expert to lead Contamination Control Strategy for a state-of-the-art sterile manufacturing facility. You will drive APS/Media Fills, EM PQ, Smoke Studies and Cleaning Validation to ensure inspection readiness and operational excellence.

You will act as SME for sterile processing, support CCS deployment, and guide risk assessments while collaborating across functions and supporting regulatory inspections with a proactive, agile mindset.