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
These requirements are absolutely non-negotiable for the suitable candidate.
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.
Responsibilities
* 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.
* Approve qualification documentation including change controls, master documents, protocols, reports, rationales, SOPs, URS, IA, QSRs and related discrepancy or non-conformance documentation.
* Contribute to system and process improvement projects while maintaining a current understanding of relevant regulations, guidance and industry practices.
Requirements
* 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.
* Strong analytical thinking and risk assessment skills.
* Excellent communication skills, with the ability to defend strategy and documentation during health authority inspections.
* Collaborative, adaptable and comfortable working cross-functionally in a changing environment.
* Fluent in both Dutch and English, written and spoken.
How to apply
If you are interested in this opportunity, please send your CV to gjohnstone@barringtonjames.com or contact +441293778666 for a confidential conversation.
You are also welcome to reach out directly via LinkedIn.