Location: Stein (Switzerland)
Relocation assistance is available for eligible candidates and their families, if needed.
Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
Become a Senior MSAT Expert at Lonza AG for an exciting Greenfield project in Stein AG Switzerland! Support the commercial readiness of a large-scale aseptic manufacturing 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
• Along with competitive salaries, you’ll find a wide range of lifestyle, family and leisure benefits available. The full list of our local benefits can be also found on assetstream.aspx

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 in alignment with regulatory requirements (e.g EU GMP, FDA, ICH). Lead and act as a 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 sterile drug product manufacturing in a GMP environment is a must, with substantial know-how in aseptic processing and sterility assurance principles.
• Experience in qualification of manufacturing equipment, cleaning validation, and room qualification is an asset.
• 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.

We are looking for someone who can find the best scientific solutions and efficiently implement them in real-world scenarios. If you are ready to collaborate at an outstanding level and deliver magnificent results, we would love to hear from you!
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference

• 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 in alignment with regulatory requirements (e.g EU GMP, FDA, ICH). Lead and act as a 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