Biotechnologist/gmp (M/F/d)
vor 14 Stunden
**Biotechnologist/GMP**
Carries out manufacturing tasks in the Drug Product area in compliance with cGMP guidelines, ensuring successful batch execution, assessing test results, addressing issues, troubleshooting manufacturing equipment, and providing recommendations for solutions
**Key responsibilities**:
- 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)
**Key requirements**:
- Completed chemical / biopharmaceutical education
- 2-4 years of experience GMP environment on the shopfloor (preferably in sterile manufacturing of Drug Product)
- Fluent English and German
Sounds like a great job?
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