(Senior) Process Engineer MSAT

Job

For our Cell & Gene Therapy organization, we are seeking a highly motivated (Senior) Process Engineer to join the Manufacturing Sciences and Technology team (MSAT). This team provides technical-scientific expertise to the GMP operations at decentralized point-of-care manufacturing units in Europe. As our (Senior) Process Engineer, you are a subject matter expert on the manufacturing process during development of the next generations of automated CAR-T, helping to drive processes/products from early clinical stage through pivotal/commercial readiness.

Your role

• Drive technology transfers and clinical manufacturing activities such as process performance qualification, aseptic process validation, regulatory submissions, scale-out, process training and technical support.
• Work on the elaboration of process descriptions, process/product risk assessments, position papers, process/product impact assessments, root-cause investigations for deviations, determine corrective actions and support implementation of change controls.
• Lead/support process validation activities through the stages of process design, process qualification and continued process verification, as well as process and product comparability.
• 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.
• Review and elaborate content of regulatory filings and health authority questions related to technical process/CMC.
• Support and lead initiatives for Data Management and Analytics for real time process/product monitoring, Cocoon equipment lifecycle and reliability.

Profile

Who are you?

• MSc/PhD degree in life sciences, biotechnology, engineering or related discipline.
• 6+ years work experience.
• Experience with cell & gene therapy processes, automated bioreactors, GMP manufacturing, technology transfer, process validation and/or process development.
• Knowledge of data management tools and statistical process controls is a plus.
• 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.

Benefits

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 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, 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 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…!

Company profile

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

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 want to challenge the impossible. 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-happeners’.