Principal Process Engineer Global MSAT Consultant

Pleased to meet you, we are Galapagos, a biotechnology company with operations in Europe and the U.S. dedicated to developing transformational medicines for more years of life and quality of life.

We are in the business of changing lives. Focusing on high unmet medical needs, we synergize compelling science, technology, and collaborative approaches to create a deep pipeline of best-in-class small molecules, CAR-T therapies and biologics in oncology and immunology. With capabilities from lab to patient, including a decentralized CAR-T manufacturing network, we are committed to challenging the status quo and delivering results for our patients, employees and shareholders.

Project Scope

The Principal Process Engineer is an experienced subject matter expert on automated CAR-T manufacturing processes and technology transfers in a decentralized manufacturing model, who drives the progress the development of the CAR-T manufacturing processes/products from early clinical stage through pivotal/commercial readiness.

Your mission

• Act as experienced subject matter expert on the automated CAR-T manufacturing process and technology transfers and clinical manufacturing in a decentralized manufacturing model.
• Develop and execute plans for Life Cycle Process Validation activities, as well as process and product comparability.
• Lead process characterization studies: design protocols, analyze data, and prepare technical reports to support process understanding and control strategies.
• Collaborate with Process Development and CMC teams to translate lab-scale processes into robust, GMP-ready manufacturing processes. Prepare and review CMC documentation, including process descriptions, comparability reports, validation protocols, and technical sections for regulatory filings.
• Provide technical input on risk assessments, control strategies, and continuous improvement initiatives aligned with global regulatory expectations.
• Support initiatives for real time process/product monitoring, manufacturing equipment lifecycle & reliability.
• Contribute to the content of regulatory filings and health authority questions related to the technical process/CMC module.

The Principal Process Engineer reports to the Director Process Engineering Global MSAT.

Who are you?

• PhD degree in life sciences, biotechnology, engineering or related discipline with at least 7 years’ work experience or MSc with an equivalent level of experience
• Demonstrated experience with cell & gene therapy processes, automated bioreactors and GMP manufacturing.
• Knowledge of Quality risk management and Quality by Design principles such as Criticality Assessment and Control Strategies
• Demonstrated experience with design and execution of process characterization studies.
• Knowledge of data management tools and biostatistics
• Excellent verbal and written communication skills with the ability to collaborate effectively across different functions and geographies.
• Result-driven and can-do mindset, without compromising quality and compliance
• Responsibility for own projects while pursuing company goals in open collaboration. Ability to be flexible with changing priorities
• Good interpersonal skills and written and spoken fluency in English

What's in it for you?

At Galapagos, we are committed to building meaningful partnerships with our consultants, offering a collaborative and supportive environment where you are recognized as an integral part of the team. As a consultant, you will engage in a variety of projects, enabling you to expand your expertise across multiple domains. Our aim is to support your professional growth while fostering a dynamic workplace that values and empowers you as an equal partner.