The Sterility Assurance Lead (SAL) is responsible for leading the Sterility Assurance and Microbial Control Program for the Drug Product Module at the Visp site. This role owns the Contamination Control Strategy (CCS) and drives a strong sterility assurance culture by partnering closely with Operations, QA, QC, Central Contamination Prevention & Control Teams, Microbiology, Engineering, and Global Technical Functions. The position ensures regulatory compliance, operational excellence, and continuous improvement across all contamination control and aseptic processing activities.
Tasks
- Own and continuously improve the Contamination Control Strategy (CCS), ensuring compliance with regulatory requirements, Lonza guidelines and industry best practices.
- Provide technical leadership and oversight for aseptic processing, aseptic process simulations (APS), sterilization, cleanroom management, and contamination control programs.
- Act as the Sterility Assurance Subject Matter Expert (SME) for facility design, technology transfers, and contamination risk assessments.
- Lead investigations, corrective and preventive actions, and root cause analyses related to sterility assurance topics.
- Manage environmental monitoring strategies, performance metrics, trend analysis, and continuous improvement initiatives to strengthen microbial control.
- Represent Sterility Assurance during health authority inspections, customer audits, and in all cross-functional platforms.
Requirements
- Academic degree in a scientific discipline with extensive experience in microbial control and sterility assurance within the pharmaceutical industry.
- Strong hands-on expertise in contamination control, aseptic processing, APS, environmental monitoring, and complex microbiological investigations.
- Deep knowledge of cleanroom engineering, sterilization processes, microbiological testing methodologies, and contamination risk management.
- Excellent communication, decision making, conflict resolution, and change management skills in complex operational environments.
- Comprehensive understanding of pharmaceutical regulations and GMP requirements.
- Strong technical knowledge of USP/EP requirements, bioburden, endotoxin, sterility testing, environmental monitoring, and contamination control systems.
- Business fluent English is required; German is an advantage.
Benefits
- An agile career and dynamic working culture.
- An inclusive and ethical workplace.
- Compensation programs that recognize high performance.
- A variety of benefits dependent on role and location.
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