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.
Located in Stein, Switzerland our successful CDMO Business Unit Drug Product Services (DPS) currently offers 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 MES Specialist DPS Growth Project 80 – 100% supporting a new sterile Drug product facility.
Key responsibilities :
Work closely with MES manager, system users and process owners to develop and revise MES recipes in a timely manner
Configure production recipes using a library of objects and manage MES master data like Products, Locations, Equipment, Materials
Assist in fulfilling requirements of quality records such as process change controls, CAPA and deviations
Draft and execute test script for the validation of recipes (IQ, OQ, PQ)
Establishment and further development of interfaces to other systems such as ERP, LIMS and automation and work closely with this departments
Development of concepts for an optimal data flow with the interfaces, taking into account all use cases
Definition of requirements for the MES system for its further development
Support production via the Helpdesk, assisting with production issues
Key requirements :
Academical degree minimum Bachelor degree preferred in a technical field and / or engineering
Proven process understanding in Sterile Manufacturing (Pharma, regulatory aspects)
Familiarity with GMP requirements, quality procedures and SOP execution
Previous exposure to any of the commercial MES systems (Rockwell PharmaSuite, Werum Pas-X, POMS, Emerson Syncade).
Good communication skills and interaction with a variety of interface within the organization and the shop floor
Strong team orientation
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 : R56288