Senior MES Expert Drug Product

Switzerland, Stein

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 Drug Product Services (DPS), our successful Contract Development and Manufacturing Organization (CDMO) branch, located in Basel, Switzerland and Stein, Switzerland, we have exciting opportunities. Become part of a group that enables its customers to meet some of the greatest challenges in patient treatment and join us by applying for the position as Senior MES System Expert Drug Product.

Key responsibilities:

  • Responsible for MES recipe creation & adaption based on the Drug Product Processes
  • Provide front line MES support working with the manufacturing teams (operators), plant engineers and QA operations
  • In charge of MES related investigations and critical deviations and Creation of related documentation (e.g. SOP’s)
  • Lead MES changes, CAPAs, and CAPA effectiveness checks related to MES within required timelines and via GMP systems (e.g. Trackwise, MES, training, etc.)
  • Planning & execution of Installation, Operational & Performance Qualification (IQ/ OQ/ PQ)
  • Be a resource to other departments as Subject Matter Expert for MES
  • Assist in decision making and provide MES training for all end user
  • Act as Subject Matter Expert during customer audits and visits providing necessary support and maintaining MES at inspection readiness level
  • Define overall concept for MES recipes used in Drug Product Operations Stein to enable straightforward and timely creation and  adaption
  • Assess and promote usage of MES and other digital tools on site and within network

Key requirements:

  • Technical education or university degree in IT, Pharmaceutical Technology, Business Informatics or equivalent
  • Good work experience in process support role on the shop floor of GMP manufacturing and/or QA/QC
  • Profound knowledge in IT, SAP and MES recipe design
  • Proven process understanding in Sterile Manufacturing
  • Good communication skills and interaction with a variety of interfaces within the organization and on the shop floor
  • Profound understanding of MES recipe design and cGMP requirements
  • Fluent in German and good English knowledge

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.

Reference: R35860