Senior Process Expert Drug Product (m/f/d)
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 we have exciting opportunities. Become part of a group working on Capital investment projects for building and commissioning of the new aseptic filling line in Stein and join us by applying for the position as Senior Process Expert Drug Product.
Work as Senior Process Expert in capital investment projects on building and commissioning of manufacturing units
Own and provide expertise to the assigned manufacturing process
Support the goal of executing each batch safely, in time and compliance with the quality requirements as well as perform batch record reviews
Execute and support technical transfer and (re-)validation projects incl. all relevant documentation
Implement and support scale-up activities of existing processes
Execute and support process improvement projects
Drive and support implementation of new technologies/equipment
Lead process related trouble shootings/investigations and deviation investigations
Use scientific and statistical knowledge to analyze data to provide process understanding, and to identify root causes of product and process failures
Maintain the assigned processes/equipment at Inspection readiness level and provide the necessary support in any internal or external audit
BSc. or MSc in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree / equivalent experience
Good work experience in process support role on the shop floor of GMP manufacturing and/or QA/QC
Profound understanding of regulatory and cGMP requirements
Proven process understanding in Sterile Manufacturing (Pharma, regulatory aspects)
Familiarity with GMP requirements, quality procedures and SOP execution
Good communication skills and interaction with a variety of interfaces within the organization and on the shopfloor
Proven IT knowledge, knowledge in SAP or MES is an asset
Lean Green Belt certification preferred
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.