Process Engineer Manufacturing Operations - EU, Leiden/NL

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 Process Engineer, Manufacturing Operations - EU

Scope

We are seeking a Process Engineer to join the Galapagos Manufacturing Operations team providing technical-operational expertise to the GMP operations at decentralized manufacturing units in Europe. The 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

• As part of 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.
• Triage operational challenges and deviations within the manufacturing process with internal stakeholders and Decentralised Manufacturing Units (DMUs) to ensure compliance and qualification.
• Coordinate activities and continuous learning and improvement of systems and procedures related to FLS within the Manufacturing Operations team scope.
• 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 Process Engineer, Manufacturing Operations – EU reports to the Lead Manager/Associate Director manufacturing operations EU. The team provides 24/7 Front Line Support performed on rotation.

• BSc/MSc in life sciences, biotechnology, engineering or related discipline.
• Experience with cell & gene therapy processes, automated bioreactors, GMP manufacturing, technology transfer, process validation and/or process development.
• Experience of Frontline Support activities and the coordination of activities related to this.
• Experience of people/project management.
• Experience of management of quality records and documentation review and writing.
• Result-driven and can-do mindset, without compromising quality and compliance.
• Responsibility for own projects while pursuing company goals in open collaboration.
• Good interpersonal skills and written and spoken fluency in English.

What’s in it for you?

You will be part of a fast growing and amazing company. As a ‘make-it-happener’ you will get all the support you need to make your job successful. At CellPoint/Galapagos we aim to recruit the best people, who stand out among their peers, with integrity and excellent interpersonal and organisational skills. Our employees are the strength behind Galapagos/CellPoint, you will join a highly motivated team, eager to maintain our leading position and to achieve breakthroughs in pharmaceutical research. New team members have the opportunity to actively shape their position and contribute to our mission. Galapagos/CellPoint offers a competitive remuneration package and a dynamic work environment. Flexible working hours can be discussed.

We are Galapagos : together we can make it happen…!