Ghent, BEL
15 days ago
QA Project Engineer MES (Manufacturing Execution Systems)
Position Title: QA Project Engineer MES, CAR-T Europe We are looking for a Quality Assurance Project Engineer who will focus on ensuring the quality of our MES (Manufacturing Execution Systems) projects for the CAR-T hub in Europe. This role involves close collaboration with various teams to support the implementation and optimization of MES solutions. The position will be based in Ghent Belgium. CAR-T (chimeric antigen receptor T-cell therapy) is an innovative approach to eliminate cancer cells, which work by harnessing the power of a patient’s own immune system. They are created from the patients’ own T cells and are engineered to eliminate cancer cells expressing a specific antigen. Major Responsibilities: + Coordinate the quality assurance process within MES projects. + Translation of production processes to MBRs and related master data take into account the strict procedures specific to the pharmaceutical industry + Responsible for QA support of Master batch records (including training and guidance) + Execute tests and quality controls to ensure the efficiency and reliability of systems. + Oversee the implementation process of MES software and applications. + Analyze system errors and propose improvements for enhanced performance. + Collaborate with internal teams to drive continuous process optimization. + Report on project progress and quality to management. + Active participation in project teams, operational teams & system teams + Close collaboration with operations, IT & automation + Support the operational and QA departments by providing coaching and/or training **Qualifications** Experience and Skills: + A bachelor’s or master’s degree in a technical field (e.g., Engineering, Computer Science, etc.). + Experience with MES systems and quality assurance in production environments is a strong advantage. + Knowledge of software testing and the implementation of technical solutions. + Strong communication skills and a solution-oriented attitude. + Ability to work independently as well as in a team setting. If you are passionate about quality assurance in the realm of MES projects and seek to make a significant impact in a dynamic environment, we invite you to apply.
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