QA Sterility Assurance Lead (SAL) - Drug Product

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.

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of. Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.

• 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.