Job Description

We are supporting one of our biggest clients in Belgium in the set-up of two brand new manufacturing facilities for the revolutionary CAR-T cell therapy.

CAR-T (chimeric antigen receptor T-cell therapy) is an innovative approach to eliminate cancer cells, by harnessing the power of a patient’s own immune system.

CAR-T cells are created from the patients’ own T cells and are engineered to eliminate cancer cells expressing a specific antigen.

To assist our client in making this a reality, we are looking for multiple Compliance Engineers with different seniority levels (junior - medior - senior). The role and responsibilities will be adapted to your experience level. Are you ready to play an active role in this developing technology? Don't hesitate and apply today!

Responsibilities

• Create/update critical quality documentation according to schedule

• Modify and write procedures at all levels of the quality and production process

• Support qualification/validation processes (change control) of equipment and processes

• Give support in deviation investigation and remediation

• Write quarterly/annual reports

• Ensure inspection/audit readiness

• Support sampling of product

• Support team to reach goals according to planning

• Complete required trainings within the prescribed time limit

• Report periodically to SPOC

• Act as SPOC or its back up

Profile

• Master of Engineering or equivalent with (bio)chemical or technical orientation

• A high professional level of English and fluent in Dutch

• Knowledge and experience in working with quality systems

• Communicative and team player

• Ability to work with data in an accurate and correct manner, and to report results clearly

• Affinity with office tools (MS office, etc.)