QA Sterility Assurance Lead (SAL) - Drug Product 80-100% (f/m/d)

The Sterility Assurance Lead (SAL) at Lonza is tasked with overseeing the Sterility Assurance and Microbial Control Program for the Drug Product Module at the Visp site. The company specializes in manufacturing medicines, with a strong focus on innovation and quality. The role involves ensuring that all contamination control and aseptic processing activities meet regulatory standards and industry best practices. The Sterility Assurance Lead's daily tasks include managing and enhancing the Contamination Control Strategy (CCS) to ensure it complies with regulatory requirements and Lonza guidelines. This involves providing technical leadership for various processes such as aseptic processing, sterilization, and cleanroom management. The role also requires acting as a subject matter expert for facility design, technology transfers, and contamination risk assessments. Additionally, the lead will handle investigations, corrective actions, and root cause analyses related to sterility assurance. They will also manage environmental monitoring strategies and performance metrics to improve microbial control. To qualify for this position, candidates must have an academic degree in a scientific discipline and extensive experience in microbial control and sterility assurance within the pharmaceutical industry. Strong hands-on expertise in contamination control, aseptic processing, and complex microbiological investigations is essential. Deep knowledge of cleanroom engineering, sterilization processes, and contamination risk management is also required. Excellent communication, decision-making, and conflict resolution skills are crucial, as is a comprehensive understanding of pharmaceutical regulations and GMP requirements. Proficiency in USP/EP requirements, bioburden, endotoxin, sterility testing, and environmental monitoring is necessary. Business fluent English is a must; proficiency in German is an advantage. Nice-to-have skills include the ability to thrive in a dynamic and inclusive workplace. The role offers an agile career path and a variety of benefits, including relocation assistance for eligible candidates and their families. The team at Lonza values diversity and is committed to creating an inclusive environment for all employees. What the role asks for: - Academic degree in a scientific discipline. - 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. - Business fluent English. - German language skills are an advantage.