Sterile Contamination Control Expert – Lead, Relocation

Lonza; Stein; On-site; Vertraulich; Full time

Benefits offered by this job

Agile career & dynamic work culture

Inclusive and ethical workplace

Competitive compensation & benefits

Job summary

Lonza Stein, AG, Switzerland seeks a Subject Matter Expert to shape the Contamination Control Strategy for a state-of-the-art sterile manufacturing facility. You will lead key initiatives ensuring regulatory compliance, inspection readiness and robust manufacturing performance throughout the product lifecycle.

This is a fully site-based role requiring close in-person collaboration to maintain technical precision and manufacturing excellence.

Qualifications

• HHands-on experience in aseptic Drug Product manufacturing, including Fill & Finish operations.
• Expertise in Cleaning Validation or Contamination Control Strategy (CCS) for sterile products.
• Strong understanding of cleanroom classifications, HVAC concepts and risk-based assessments.

Responsibilities

• Act as Subject Matter Expert for Sterility Assurance and Contamination Control.
• Support the facility-wide Contamination Control Strategy (CCS) implementation and lifecycle.
• Lead key programs: APS/Media Fills, Environmental Monitoring PQ, Smoke Studies and validation activities.
• Develop, optimize and sustain Cleaning Validation protocols and lifecycle programs.
• Drive investigations, deviations, CAPAs and cross-functional continuous improvement.

Skills

Aseptic manufacturing

Cleaning Validation / CCS

Cleanroom concepts / HVAC

Regulatory inspections experience

Cross-functional collaboration

Education

Engineering / Life Sciences degree

Job description

Lonza Stein, AG, Switzerland seeks a Subject Matter Expert to shape the Contamination Control Strategy for a state-of-the-art sterile manufacturing facility. You will lead key initiatives ensuring regulatory compliance, inspection readiness and robust manufacturing performance throughout the product lifecycle.

This is a fully site-based role requiring close in-person collaboration to maintain technical precision and manufacturing excellence.