Hoofddorp
jobid=A.0.174
Walker Cole International is currently searching for a MSAT Process Engineer for a cell & gene company based in the Netherlands. This is a 6-month contract working on a hybrid basis for a leading ATMP company, with the option of extension.
Your responsibilities as the MSAT Process Engineer will be:
- Serve as a subject matter expert in automated CAR-T manufacturing, technology transfers, and clinical production within a decentralised model.
- Develop plans to advance Life Cycle Process Validation, covering process design, qualification, verification, and comparability.
- Oversee product and process-related change controls across the global network.
- Lead investigations, identifying and implementing corrective and preventive actions.
- Prepare process descriptions, SOPs, work instructions, and training materials to support decentralised manufacturing.
- Assist in developing electronic batch records, procedures, and training for manufacturing processes.
- Support real-time process and product monitoring, as well as equipment lifecycle and reliability initiatives.
- Contribute to regulatory filings and responses to health authority queries related to technical processes and CMC.
Requirements for MSAT Process Engineer:
- Degree in Life Sciences, Biotech or related field with a minimum 7 years of work experience
- Demonstrated experience with cell & gene therapy processes, automated bioreactors, GMP manufacturing, technology transfer, process validation and/or process development
- Excellent verbal and written communication skills with the ability to collaborate effectively across different functions and geographies.
- 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. Ability to be flexible with changing priorities
- Good interpersonal skills and written and spoken fluency in English
Process Engineer | MSAT Process Engineer | Senior Process Engineer | Pharmaceutical | Biotech | Cell & Gene | ATMP | Process Engineering
