Process Validation Engineer - (CAR-T EMEA)

Process Validation Engineer – Cell Therapy (CAR-T)

Role Overview

This role supports the start-up and expansion of CAR-T manufacturing operations in Europe, contributing to the delivery of innovative cell therapies for cancer treatment. As part of a Manufacturing Excellence environment, the Process Validation Engineer plays a key role in technology transfer, validation strategy, and the implementation of robust, compliant manufacturing processes at a new production site in Ghent.

The position offers the opportunity to work on cutting-edge cell therapy technologies within a highly regulated GMP environment, supporting pilot plant implementation and long-term operational readiness.

Key Responsibilities

• Define, plan, and coordinate validation activities, including sterilization, hold time validation, APS, and APQ

• Develop, review, and approve validation plans, protocols, and reports

• Ensure ongoing compliance through revalidation of manufacturing and sterilization processes

• Support technology transfer, equipment introduction, and system implementation activities

• Contribute to process optimisation and continuous improvement initiatives

• Review technical documentation to ensure alignment with regulatory expectations and industry best practices

• Collaborate with cross-functional teams across manufacturing, quality, and technical disciplines

Required Qualifications and Experience

• Bachelor’s degree or higher in Engineering, Biotechnology, Biomedical Sciences, Pharmacy, or a related discipline

• 4–6 years of experience in pharmaceutical, biotechnology, cell therapy, or similarly regulated industries

• Strong working knowledge of cGMP requirements

• Hands-on experience with validation activities in regulated manufacturing environments

• Fluency in both English and Dutch (written and spoken)

Key Skills

• Experience leading or coordinating sterilization and aseptic process validation activities

• Strong technical writing capability for validation documentation

• Solid project management and organisational skills

• Ability to work independently while contributing effectively within cross-functional teams

• Strong problem-solving mindset and attention to detail

Nice to Have

• Experience in cleanroom or aseptic manufacturing environments

• Exposure to CAR-T, cell therapy, or advanced therapy medicinal products (ATMPs)

• Experience supporting pilot plants, tech transfers, or greenfield manufacturing sites