Fixed-term contract
ASAP start through to the end of 2026
Must be based in the Flemish Region, Belgium, and legally able to start work immediately
Must speak English and Dutch fluently
I am supporting a confidential client on an opportunity for an experienced QA C&Q Engineer to join a specialist team working within an advanced, highly regulated environment focused on innovative cell therapy manufacturing.
Support the QA Qualification Team by reviewing and approving qualification and requalification activities across facilities, utilities and process equipment.
Work closely with asset management and engineering teams to safeguard the qualification status of critical production assets.
Ensure that system-critical aspects relating to facilities, utilities, product and process requirements are identified, controlled and supported by robust mitigation plans.
Review deviations linked to equipment issues, assess any quality or compliance impact, and ensure appropriate investigations and CAPA actions are defined and implemented.
Partner with manufacturing teams to approve change controls and manage deviations effectively.
Build strong working relationships across multiple quality organisations.
Review and approve procedures, calibration rationales, calibration master forms, completed calibration records, master data set-up, maintenance plans and data integrity deliverables such as audit trail and user access reviews.
Support preparation for regulatory and customer inspections and act as a QA qualification spokesperson where required.
Master’s degree in engineering with a chemistry or analytical background, or in pharmaceutical sciences.
Strong awareness of quality and a solid understanding of cGMP regulations and FDA/EU guidance relevant to cell therapy manufacturing.
Experience working with computerised systems, system parameter configurations and data management in critical production assets.
Fluent in both Dutch and English, written and spoken.