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As a Subject Matter Expert in your assigned process steps, you will provide front line technical and procedural support to the shopfloor in the area of Drug Product, according to cGMP guidelines. You will work with the manufacturing team, engineers and QA operations, troubleshooting manufacturing processes and making recommendations for resolution. You will drive improvement projects in the manufacturing processes.
Tasks
- Execute 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.
- Provide front line technical and procedural support, working with the manufacturing team, engineers and QA operations.
- Ensure each batch is manufactured safely, on time, in compliance with the batch instructions and quality requirements.
- Establish timely and high-quality production documentation (preparation and review of electronic batch records) or other relevant GMP documents for the assigned production area.
- Proactively drive optimization projects for manufacturing processes.
- Own process related investigations and critical deviations and assist in decision making on production issues.
- Drive 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.
- Perform training activities of relevant areas.
Requirements
- Bachelor or Master Degree preferred, in Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree.
- 3-5 years of experience in Sterile Manufacturing in operations (preferably compounding, filtration, steam sterilization, single use systems); some experience in QA is an advantage.
- Fluent in English; German is an advantage.
- Familiarity with GMP requirements, quality procedures, SOP execution, deviations/investigations management.
- 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.
- High motivation and collaboration focused; solution-oriented and scientifically driven.
- Prepared to work flexible working hours.
Benefits
- A working environment in a motivated and inclusive team.
- An up to date production line in constant progress for improvements.
- An agile career and dynamic working culture.
- An ethical workplace.
- Compensation programs that recognize high performance.
- A variety of benefits dependent on role and location.
- Relocation assistance is available for eligible candidates and their families, if needed.
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Über uns
Lonza Group AG ist ein international tätiges Unternehmen für die Pharma-, Biotech- und Life-Science-Industrie. Das Unternehmen entwickelt und produziert Wirkstoffe, biopharmazeutische Produkte sowie spezialisierte Lösungen und unterstützt Kunden von der frühen Entwicklung bis zur industriellen Herstellung. Zudem stellt Lonza chemische und biotechnologische Komponenten für Anwendungen in Gesundheit, Ernährung und weiteren Industrien her.