Job Title: QA Project Engineer MES, CAR-T Europe
We are seeking a QA Project Engineer to support MES (Manufacturing Execution Systems) projects for CAR-T therapy hubs in Europe. You will help digitize documentation, ensure compliance with GMP standards, and collaborate with cross-functional teams to improve processes in an innovative therapy environment.
Collaborate with production and engineering teams to digitize and standardize documentation.
Review validation deliverables such as PQ protocols, test documentation, and traceability matrices.
Conduct risk assessments, deviation management, and change control reviews.
Participate in audits, inspections, and internal quality reviews.
Provide QA guidance, training, and support to ensure adherence to compliance standards.
Support QA approval of GMP documentation and attend quality review meetings.
Actively participate in project, operational, and system teams alongside IT and automation functions.
Bio-Engineer, (Industrial) Pharmacist, or bachelor’s/master’s degree in a technical field (Engineering, Computer Science, etc.).
Minimum 2 years’ cross-functional experience in the pharmaceutical industry.
Knowledge of cGMP regulations and pharmaceutical compliance requirements.
Experience with master batch records and/or QA in production environments.
Experience with MES systems in production environments is a strong advantage.
Ability to work independently and in a team environment.
Start Date: ASAP
Employment Type: Full time