Process Validation Engineer Cell Therapy

Our client, a leading biotechnology organization, is seeking a professional to support the start-up of a new production facility. The project focuses on technical transfers, sterilization validation, and equipment introduction to expand therapeutic manufacturing capacity. This role ensures that all manufacturing processes are developed and validated according to the highest industry standards.

• Define strategies and coordinate validation activities including PPQ, smoke studies, hold time validation, and APS.
• Provide technical guidance on all aspects of validation and qualification for the manufacturing site.
• Manage the revalidation of manufacturing and sterilization processes to ensure continuous compliance.
• Draft, review, and approve validation plans, protocols, and reports for APS and sterilization procedures.
• Contribute to product transfer and system introduction teams to facilitate site development.
• Lead system and process improvement projects focused on operational optimization.
• Monitor technical reports to ensure procedures align with current cGMP and regulatory requirements.

• You have a Bachelor’s degree or higher in engineering, biotechnology, biomedical sciences, or pharmacy.
• You bring experience in the pharmaceutical or biotechnology industry, specifically with product introductions and manufacturing unit operations.
• You possess a strong working knowledge of cGMP and validation methodologies.
• You have experience in project management and the ability to provide accurate reporting on project activities.
• You're a proactive team player with strong problem-solving skills and the ability to work under pressure and manage priorities.
• You are fluent in Dutch and English.

Nice to Haves

• Experience working in a controlled cleanroom environment under aseptic conditions.

• Enjoy a competitive salary package with extra perks that recognize your talent.
• Advance your career with a clear growth path, coaching, and mentoring to support you.
• Thrive in a dynamic and supportive environment where you can truly make an impact.
• Work when and where you perform best, ensuring an optimal work-life balance.
• Choose a flexible transport solution, from a company car to a public transport subscription.
• Expand your network and enjoy unforgettable moments at exclusive events and afterworks.
• Grow your skills with external courses and our in-house Pauwels Academy.
• Work on exciting projects with industry leaders in Life Sciences, Engineering & Digital.
• Seize opportunities at every level, from a strong start to career acceleration and expert collaboration.