Process Validation Engineer

il y a 16 heures


Ghent, Belgique Panda International Temps plein

Process Validation Engineer – Cell Therapy | CAR-T (EMEA)Our client is active in the development, manufacturing, and commercialization of CAR-T cell therapies in partnership with a leading biotechnology organization. Together, they are advancing an innovative immunotherapy platform aimed at treating blood cancers and addressing unmet medical needs.CAR-T therapy is a cutting-edge treatment that leverages a patient's own immune system. By genetically modifying T-cells to target and eliminate cancer cells, this technology offers new hope to patients for whom existing therapies have shown limited or no success. To support the continued growth of this therapy in Europe, a new state-of-the-art manufacturing facility is being developed in Ghent, Belgium.The RoleAs a Process Validation Engineer, you will be part of the Manufacturing Excellence team and play a key role in the start-up and scale-up of CAR-T manufacturing operations in Ghent. The manufacturing process is being transferred from the US to Europe, with a strong focus on the implementation of the pilot plant.You will be actively involved in technology transfer, validation planning, sterilization validation, equipment introduction, and technical documentation.Key ResponsibilitiesDefine validation strategies and coordinate activities such as sterilization validation, hold-time studies, APQ and APSProvide guidance on validation and qualification activitiesEnsure timely revalidation of manufacturing and sterilization processesWrite, review, and approve validation plans, protocols, and reports (including sterilization and APS)Participate in product transfer and system introduction teamsContribute to process improvement and optimization projectsReview technical documentation to ensure compliance with current industry standards, regulatory requirements, and technologiesExperience & SkillsExperience in pharmaceuticals, biotechnology, cell therapy, plasma-derived products, or a related industryExperience introducing pharmaceutical products into manufacturing sites and supporting late-stage developmentStrong knowledge of cGMPExperience in aseptic / cleanroom environments is a plusProject management skills with clear and timely reportingAble to interact effectively at multiple organizational levelsComfortable working under pressure and managing competing prioritiesAble to work independently with strong prioritization skillsTeam-oriented with a problem-solving mindsetFluent in Dutch and English (written and spoken)5–7 years of relevant experience


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