Executes manufacturing activities in the area of Drug Product according to cGMP guidelines, ensuring batch execution, evaluating test results, resolving issues, troubleshoot manufacturing equipment and make recommendations for resolution.
Provides front line technical and procedural support, working with the manufacturing team.
Securing each batch is manufactured safely, on time, in compliance with the batch instructions and quality requirements
Responsible for establishing timely and with high quality the required production documentation (preparation, execution and review of batch records) or other relevant GMP documents for the assigned production area.
Supports process related investigations and assists in decision making on production issues
Supports process changes and CAPAs related to processes within required timelines
Performs training activities of relevant areas as operator and supports others and new joiners.
Operating, setting up and cleaning production equipment and premises for the production of liquid and freeze-dried drug forms (e.g.:compounding, parts washing, autoclaving, filter integrity testing, visual inspection)
Requirements
2-4 years of experience GMP environment on the shopfloor (preferably in sterile manufacturing of Drug Product)
Fluent in either English or German (preferably both)
Familiarity with GMP requirements, quality procedures and SOP execution
Strong team orientation
Effective communication skills and interaction with a variety of interfaces within the organization
Structured, focused, and well-organized working attitude
High motivation and dynamic drive
IT knowledge and knowledge in SAP and MES is a benefit
Prepared to work in 2 shifts pattern
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.
Additional Information
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.
Lonza · Switzerland