MSAT Process Engineer

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
Seniority level  Mid-Senior level

Employment type

Contract
Job function  Engineering, Manufacturing, and Science
Industries  Pharmaceutical Manufacturing

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