MSAT Process Engineer

Walker Cole International; Hoofddorp; Hybrid; USD 69,824 - 116,374; Full time

Job summary

An innovative firm is seeking a skilled MSAT Process Engineer to contribute to cutting-edge cell and gene therapy projects. This role involves overseeing automated CAR-T manufacturing processes, ensuring compliance with GMP standards, and leading investigations for continuous improvement. You will develop crucial documentation and collaborate across functions to enhance production efficiency. This is a fantastic opportunity to work in a dynamic environment that values quality and innovation, with the potential for contract extension. If you are passionate about advancing biotechnological solutions, this position is perfect for you.

Qualifications

• Minimum 7 years of experience in cell & gene therapy processes.
• Strong knowledge of GMP manufacturing and process validation.

Responsibilities

• Serve as a subject matter expert in automated CAR-T manufacturing.
• Oversee product and process-related change controls globally.

Skills

Automated CAR-T manufacturing

Technology transfer

Clinical production

Process validation

GMP manufacturing

Data management tools

Statistical process controls

Excellent communication skills

Interpersonal skills

Education

Degree in Life Sciences

Degree in Biotech

Job description

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