Manufacturing Specialist
Vor 6 Tagen
In this role, you will be responsible for executing operational activities of assigned manufacturing projects in specific areas (Up-stream or Down-stream processing).
Key Responsibilities:- Execute manufacturing activities in either the Upstream Processing or Downstream Processing area according to cGMP guidelines, ensuring batch execution, evaluating test results, resolving issues, troubleshooting manufacturing equipment and making recommendations for resolution.
- Support the preparation of Safety, Health, Environment risk assessment for the assigned products and the implementation and control of defined measures.
- Assist in document preparation (e.g. electronic batch records, SOPs) specific to the assigned production area.
- Review production documentation and work on deviations, change requests, and implementation of CAPAs to ensure high-quality GMP standards.
- Engage in Capital investment projects for building and commissioning of new manufacturing units as a manufacturing expert. Responsible for delivering all input required for the specific set-up, commissioning, and qualification of the manufacturing suites and equipment.
- Responsible for the training of the manufacturing staff on specific equipment or standard operations.
- Completed chemical / biopharmaceutical education or corresponding training qualification, Bachelor / Master's degree in Biotechnology, Biology, Biochemical Engineering or related disciplines is an advantage.
- Sound knowledge of biotechnological processes either in the area of microbial and/or mammalian cultivation or in the area of protein purification.
- Excellent communication skills, team player, driven and solution-oriented.
- Fluency in English required, fluency in German is considered a plus.
- Open to work in shift (4-shift system).
- Basic GMP understanding is a plus.
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