Process Validation Engineer

il y a 3 jours


Ghent, Belgique Panda International Temps plein

Process Validation Engineer – Cell Therapy (CAR-T)Role OverviewThis 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 ResponsibilitiesDefine, plan, and coordinate validation activities, including sterilization, hold time validation, APS, and APQDevelop, review, and approve validation plans, protocols, and reportsEnsure ongoing compliance through revalidation of manufacturing and sterilization processesSupport technology transfer, equipment introduction, and system implementation activitiesContribute to process optimization and continuous improvement initiativesReview technical documentation to ensure alignment with regulatory expectations and industry best practicesCollaborate with cross-functional teams across manufacturing, quality, and technical disciplinesRequired Qualifications and Experience4+ years of experience in pharmaceutical, biotechnology, cell therapy, or similarly regulated industriesStrong working knowledge of cGMP requirementsHands-on experience with validation activities in regulated manufacturing environmentsFluency in both English and Dutch (written and spoken)Key SkillsExperience leading or coordinating sterilization and aseptic process validation activitiesStrong technical writing capability for validation documentationSolid project management and organizational skillsAbility to work independently while contributing effectively within cross-functional teamsStrong problem-solving mindset and attention to detail



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