MSAT Validation Specialist (m/w/d) 100%

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.

For Ibex™ Solutions (www.ibex.lonza.com), our unique biological manufacturing and development concept in Visp, Switzerland, we have multiple openings. Become part of this exciting opportunity and join our team by applying for the position as MSAT (Manufacturing Science and Technology) Process Validation Expert.

In this role, you will be responsible for successful validation of process transfer, scale up and optimization in the biopharmaceutical plants, including process characterization, validation activities at scale, continued process verification and Product Quality Reviews (PQRs). You will significantly contribute to the development of the MSAT Bio validation group and share the responsibility as a long-term process validation expert.

Key Responsibilities

• Designing process validation strategy for bio processes at Lonza

• Preparation of validation documents (study design / writing protocols and reports) according to Lonza procedure and in compliance with regulatory guidance

• Leading the process validation teams including communication with customers

• Supporting R&D teams during the process characterization phase. Reviewing and approving of process characterization documents

• Responsibility for the validation assessment on changes and deviations (approval of deviation and changes)

• Preparation and maintenance of a documented continued process verification plan

• Assessing and approving of Product Quality Reviews

Key Requirements

• Master in Chemistry, Biotechnology, Life Sciences or related field

• Experience in project management, preferable in MSAT, Quality and Compliance

• Experience in interaction with different stakeholders within an organization and with regulatory agencies (Swissmedic, FDA etc.) would be an advantage

• Fluent communication in English (written and spoken), additional fluent communication in German is appreciated

• Ability to work on different tasks simultaneously and to work towards deadlines

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.