One of the world's leading private biotechnology companies, developing and manufacturing innovative biotechnology-based medicines for human healthcare products, with a focus on microbial-derived biologics .
To contribute to a culture of manufacturing excellence through participation in Technology Transfer into and execution of manufacturing operations within production facilities.
* Operation of Upstream, Downstream and analytical equipment as required by role
* Aseptic technique as required by role
* Environmental Monitoring if required
* SAP interaction
* Office skills: Word, Excel, Powerpoint, Trackside
1. Interact with R&D and Engineering personnel as part of a programme team to support Technology Transfer of projects into the manufacturing facilities and to conduct plant and process troubleshooting during manufacture.
2. Execute Technology Transfer and manufacturing activities to achieve manufacture schedule targets, this will include:
* Ensuring facility readiness to manufacture in accordance with relevant checklists and procedures.
* Understanding and executing production plans with limited guidance.
* Execution of manufacturing operations according to Batch Manufacturing Records and associated Work Instructions.
* Ensure accurate management of Raw Materials and consumables in SAP.
3. The job holder will understand the requirements of GMP (e.g. Purpose of a BMR, role of a Witness, Good Documentation Practice) and ensure accurate data recording of executed tasks and activities in Quality documentation including but not limited to Batch Manufacturing Records, Logbooks and Qualification Protocols.
4. Ensure appropriate training status for all tasks and activities to be undertaken and ensure these tasks and activities are performed in a safe and compliant manner.
5. Identify and appropriately report all potential safety risks and violations.
6. Identify and appropriately report all deviations from defined operating procedures.
7. Demonstrate ownership of designated equipment and systems.
8. Any other duties commensurate with grade.