Process Engineer PoC Operations EU
23 uur geleden
About Galapagos
We are a dynamic growing Biotech company with offices across Europe and in the US, headquartered in Mechelen, Belgium. Our mission is to discover and develop life-improving medicines, and we're looking for talented individuals to join our team.
Job Summary
We're seeking a highly motivated (Senior) Process Engineer to join our Cell & Gene Therapy organization in Leiden/NL. As a Process Engineer, you will be responsible for driving technology transfers and clinical manufacturing activities, ensuring compliance and qualification/batch progress, and leading operational activities through the stages of technology transfer and continued operations.
Key Responsibilities
- Drive 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.
What We Offer
As a Process Engineer at Galapagos, you will have the opportunity to work on cutting-edge projects, collaborate with a talented team, and contribute to the development of life-improving medicines. We offer a dynamic and supportive work environment, competitive compensation and benefits, and opportunities for professional growth and development.
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