Overview
Location: Stein, AG, Switzerland. The actual job location is in Stein, AG, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed. Lonza is seeking an MSAT Expert for an exciting Greenfield project in Stein, Switzerland. Support the commercial readiness of a large-scale aseptic fill&finish facility for biologics. What You’ll Get
An agile career and dynamic working culture An inclusive and ethical workplace Compensation programs that recognize high performance Competitive salaries with a wide range of lifestyle, family and leisure benefits (local benefits available) Key responsibilities
Act as the MSAT Expert in capital investment projects to build and commission manufacturing units, ensuring commercial readiness for the GMP manufacturing facility. Define qualification strategies and concepts for DP manufacturing equipment and clean rooms as part of the aseptic fill&finish lines in alignment with regulatory requirements (e.g., EU GMP, FDA, ICH). Lead and act as an MSAT member in cross-functional project teams (e.g., QA, Engineering, Manufacturing, QC). Provide technical leadership during the design of the sterile manufacturing processes, including cleanroom layout, material/personnel flow, and equipment placement. Craft the Aseptic Process Simulation concept in alignment with internal guidelines and regulatory requirements. Provide oversight and technical support during execution of APS and all investigations regarding the aseptic manufacturing process. Support the development of aseptic technique training programs. Lead risk assessments (e.g., FMEA) to identify critical manufacturing process parameters and control strategies for the facility. Author and review GMP documents such as Qualification/Validation master plans, protocols and reports, SOPs, manufacturing concepts, etc. Ensure GMP documentation readiness for authority inspections in line with internal and external quality standards. Contribute to the development and implementation of standardized MSAT procedures and processes, including qualification standards, single-use systems, and filtration systems. Key requirements
University degree or equivalent technical education in Biotechnology, Pharmacy, or a related field Significant experience in aseptic/sterile fill&finish processes of drug products in a GMP environment; strong know-how in aseptic processing and sterility assurance principles. Experience in at least one of the following: qualification of manufacturing equipment; cleaning validation; room qualification Strong communication skills, able to translate complex technical topics into clear actionable messages. Proactive, positive approach, problem-solving attitude, and ability to take full responsibility for assigned areas. Ability to lead cross-functional teams and drive decision-making in a matrix organization; build strong networks and trust across internal and external stakeholders. Proficiency in English is a must; German language skills are a plus. About Lonza
At Lonza, our people are our greatest strength. 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.
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