Process Validation Engineer

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 therapy has shown remarkable promise in clinical trials. The Process Validation Engineer will play a crucial role in ensuring the quality and consistency of our cell therapy products throughout the entire development process, from early-stage research to commercialization. This includes designing, implementing, and validating processes for cell collection, processing, and storage, as well as collaborating with cross-functional teams to develop and implement testing strategies. The ideal candidate will have a strong background in biotechnology, cell biology, or a related field, and experience working in a GMP-compliant environment. A Master’s degree in a relevant field is required, and a Ph.D. is preferred. The Process Validation Engineer will be responsible for: • Designing, implementing, and validating processes for cell collection, processing, and storage; • Collaborating with cross-functional teams to develop and implement testing strategies; • Ensuring the quality and consistency of our cell therapy products throughout the entire development process; • Developing and maintaining documentation related to process validation activities; • Participating in audits and inspections as required; • Staying up-to-date with industry trends, regulatory requirements, and best practices. In return for your expertise, we offer a competitive salary, comprehensive benefits package, and opportunities for professional growth and development.