Cleaning Validation Expert

Location – Stein, Switzerland

Today, Lonza is a global leader in life sciences operating across three 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.

As a Cleaning Validation Expert working in MSAT (Manufacturing Science & Technology) department, you are responsible for the successful construction and execution of the cleaning validation strategy in the sterile Drug Product Manufacturing facilities in Stein

Key Responsibilities:

• Responsible for the preparation and owner of the Cleaning Validation Master Plan for the entire fill and finish Stein facilities
• Lead the cleaning concept of the process equipment for the facilities, which includes for example small and large molecules, highly potent drugs / ADC as well as BSL-2
• Prepare, coordinate, perform and maintain cleaning validation activities in compliance with cGMP regulations and specification requirements.
• Define the strategy for cleaning validation including direct, indirect, no contact format parts, CIP and corresponding holding times.
• Provide support to cross functional Technical Transfers / New Product Introduction evaluation including support to cross contamination risk assessments, PDE calculation, validation methods…
• Define and coordinate the usage of third party companies to provide support of the validation execution.
• Owner of the Cross Contamination Control Strategy of the facilities.
• Be a fronter during customer audit and international authorities inspections as cleaning validation SME.
• Contributing to the development and implementation of standardized MSAT procedures and processes, in link with global MSAT department.
• Proactively anticipates, evaluates and resolves technical challenges within area of expertise, including deviation related to validation.
• Training and transfer of knowledge to the manufacturing teams during cleaning validation execution

Key requirements:

• Proven process understanding in Sterile Manufacturing (Pharma, regulatory aspects)
• In depth knowledge of risk assessments related to cross contamination prevention
• Previous working experience with BSL-2 and ADC products is an asset
• Strong knowledge of GMP and regulatory validation requirements
• Very good communication skills and interaction with all kinds of interfaces within customers and the organization; strong team orientation and collaboration across groups and Lonza sites.

• Structured, focused and well-organized working attitude
• Open-minded for new ideas and suggestions; agile, highly motivated and dynamic drive; solution-oriented

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.

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