Beschreibung
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
Befähigungen
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.