Process Engineer: Driving Innovation in Cell
4 dagen geleden
At Galapagos, we’re committed to changing lives through innovative biotech solutions. As a highly motivated Cell & Gene Therapy organization in Leiden/NL, we’re seeking a visionary (Senior) Process Engineer to join the Point-of-Care Manufacturing team (PoC)\. This team provides technical-operational expertise to the GMP operations at decentralized point-of-care manufacturing units in Europe\. As our (Senior) Process Engineer, you’ll be a subject matter expert on the manufacturing process during operations and Technology Transfer activities of automated CAR-T, driving operations from site selection through clinical/pivotal/commercial readiness\. Your responsibilities will include:
- Driving technology transfers and clinical manufacturing activities such as process performance qualification, aseptic process validation, regulatory submissions, scale-out, process training and technical support\.
- Triage operational challenges and deviations with internal stakeholders and Point-of-Care Manufacturing units (PMUs) to ensure compliance and qualification/batch progress\.
- Lead/support operational activities through the stages of technology transfer and continued operations, as well as training and continuous improvement activities\.
- Ensure consistency and control of the cell therapy manufacturing processes using a digital and fully automated cell culturing platform\. Write and review electronic batch records, SOPs, protocols & reports\.
- Perform data trending and analysis for Key Performance Indicators related to operational performance\.
- Support and lead initiatives for equipment, facility and engineering workstreams related to manufacturing at PMUs and interact with external stakeholders and vendors where required to drive improvements\.
As our (Senior) Process Engineer, you will report to the Manager/Associate Director PoC Operations\.
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