The Biologics Pilot Plant (BPP) is manufacturing biological Drug Substance for human use, and is a multiproduct facility, with several different products/manufacturing campaigns per year.
The mission consists of supporting the manufacturing activities on-going in the facility as well as the manufacturing activities happening at our manufacturing partners facilities. This candidate will be part of the BPP process engineering team.
This candidate will act as one of the experts in manufacturing of biologics at industrial scale within the entire biotech organization, impacting the development of pipeline of biotech processes.
This candidate has special focus (>30% of his/her time) on automation & acts as BPP SME in execution, troubleshooting & improvement of BPP automation needs.
- Perform the transfer of processes from small-scale development units to the pilot plant and from pilot plant to commercial manufacturing sites. (Manufacturing/Process Description, mass balance, end of campaign summary meetings, risk assessment, campaign reports, lessons learnt)
- Act as BPP automation expert to support primarily Zeta & PCS7 and to a later stage other automation tools (e.g. UniCorn)
- Support manufacturing teams by being a process and process equipment expert. He/she will take part / lead troubleshooting challenges faced during the execution of process, in compliance with cGMP rules.
- Lead the design of new - or modified process equipment, (re-) qualification of equipment, (re-) validation.
- Drive/Support continuous improvements of equipment, systems and methods to increase Biologics Pilot Plant efficiency.
- Set-up and improve (scale-up) methods and tools to efficiently and robustly perform transfers of processes.
- Set-up effective process monitoring, data management and process learning, identify, develop and implement potential process improvements.
- Work closely with other SMEs to standardize operational practices and monitoring among the different areas/scales.
- Lead/support deviations (Creation, Root Cause assessment, Impact Analysis, CAPA definition and execution, investigations) and change controls (new process introduction, technical modifications of the facilities)
- Mentor and supervise junior process engineers