Senior Process Engineer, Manufacturing Operations - EU

Pleased to meet you, we are Galapagos, a dynamic growing Biotech company with offices across Europe and in US, headquartered in Mechelen, Belgium.

We’re in the business of changing lives. In our quest to discover and develop life-improving medicines we go where no one has ever gone before. In every challenge we face, we see new opportunities. We pioneer for patients. We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters. Collaborative innovators and perseverant idealists. We need the best-in-class. In other words, we need you : The ‘make-it-happener’.

For the Galapagos organisation in Leiden/NL, we are looking for a Senior Process Engineer, Manufacturing Operations - EU.

Scope 

We are seeking a Senior Process Engineer to join the Galapagos Manufacturing Operations team providing technical-operational expertise to the GMP operations at decentralized manufacturing units in Europe. The senior manufacturing operations process engineer is a subject matter expert on the manufacturing process during operations of automated CAR-T, helping to drive operations through clinical/pivotal/commercial readiness.

Your role

• Lead the Manufacturing Operations team perform Front Line Support activities such as process monitoring, deviation triage, technical support, issue resolution, process and equipment troubleshooting and technical support.
• Lead the coordination of activities, continuous development and improvement of systems and procedures related to DMU (Decentralised Manufacturing Unit) operations within the Manufacturing Operations team scope.
• Support the process engineers within the team with the routine communication between the manufacturing team and DMUs.
• Together with the manufacturing lead/manager, maintain oversight of DMU status in alignment with internal and external stakeholders.
• Triage operational challenges and deviations within the manufacturing process with internal stakeholders and DMUs to ensure compliance and qualification.
• Ensure consistency and control of the manufacturing processes using a digital and fully automated cell culturing platform. Write and review electronic batch records, SOPs, protocols & reports relating to clinical readiness and Tech Transfer.
• Perform data trending and analysis for Key Performance Indicators related to operational performance of manufacturing.

The Senior Process Engineer, Manufacturing Operations – EU reports to the Lead Manager/Associate Director manufacturing operations EU.