Process Expert Drug Product
vor 1 Tag
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.
**Key responsibilities**:
- Implements manufacturing activities in the area of Drug Product according to cGMP guidelines, ensuring batch execution, evaluating batch data, resolving issues, troubleshooting manufacturing processes and making recommendations for resolution.
- Provides front line technical and procedural support, working with the manufacturing team, engineers and QA operations
- Securing each batch is manufactured safely, on time, in compliance with the batch instructions and quality requirements
- Responsible to establish timely and with high quality the required production documentation (preparation and review of electronic batch records) or other relevant GMP documents for the assigned production area.
- Proactively driving optimization projects for manufacturing processes
- Owns process related investigations and critical deviations and assists in decision making on production issues
- Drives process changes, CAPAs, and CAPA effectiveness checks related to process within required timelines and through GMP systems (e.g. Trackwise, SAP, MES, training, etc.)
- Be a resource to other departments as Subject Matter Expert
- Performs training activities of relevant areas
- Drives innovation and improvement projects comprising general manufacturing aspects for the production plant
**Key requirements**:
- Bachelor / Master Degree or relevant experience preferred
- Preferred area of study: Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree
- Min of 1 year of experience in Sterile Manufacturing on the shopfloor and/or QC/QA
- Familiarity with GMP requirements, quality procedures and SOP execution
- Good communication skills and interaction with a variety of interfaces within the organization and within the shopfloor
- Structured, focused, proactive and well-organized working attitude
- Focused on collaboration and motivation; guided by scientific principles
- Prepared to work flexible working hours
- Proficient in English, German is an advantage
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.
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