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Process Engineer PoC Operations EU
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About Galapagos
We are a dynamic and 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 that change lives.
Job Summary
We are 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 technology transfer and continued operations.
Key Responsibilities
- Drive technology transfers and clinical manufacturing activities, including 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, and 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 our (Senior) Process Engineer, you will report to the Manager/Associate Director PoC Operations. We offer a dynamic and challenging work environment, opportunities for professional growth and development, and a competitive compensation package.
