MES Engineer

Description

The company works across medicines and medical technology. This role sits in the Manufacturing Asset Management group in Ghent, Belgium, within Supply Chain Engineering and Manufacturing Engineering.

The team supports CAR-T, a cell therapy that modifies a patient's own T-cells so they target and destroy cancer cells, for patients whose standard treatments no longer work well enough.

You will act as the MES Engineer for PAS-X, the manufacturing execution system used for CARVYKTI production.

The role suits someone who wants to build expertise where cell therapy manufacturing, digital systems and operational excellence meet.

Hiring steps: your CV is reviewed, and if it fits, a recruiter calls you briefly. The team keeps you informed throughout, and successful candidates complete country-specific checks before starting. You may also be asked to fill in a short feedback survey afterwards.

Responsibilities

• Design, configure and maintain PAS-X MES solutions for manufacturing processes across the CARVYKTI production lifecycle.
• Turn business and operational needs into compliant MES designs and system improvements.
• Build and maintain electronic batch records, workflows, master data and system settings.
• Keep MES solutions aligned with changing business needs, GMP requirements and site standards.
• Help qualify and validate MES deployments, enhancements and periodic updates.
• Write and review validation documents, such as requirements, risk assessments, test protocols and summary reports.
• Organise testing with Operations, Quality, Validation and IT colleagues.
• Make sure every MES change meets applicable quality and compliance rules.
• Act as the technical MES expert and help operations resolve system issues.
• Investigate MES incidents, deviations and system events to limit operational impact.
• Contribute to knowledge management, user training and support documentation.
• Oversee MES master data so it stays accurate, consistent and compliant throughout its life.
• Support controlled rollout of process updates, recipes, materials, equipment models and workflow changes.
• Keep data trustworthy and traceable through MES processes and integrations.
• Take part in upgrades, patching and platform improvements.
• Find ways to raise manufacturing efficiency, compliance and user experience through MES changes.
• Support projects and change work from requirements gathering through deployment.
• Encourage innovation and continuous improvement within the CAR-T manufacturing environment.
• Help shape the MES roadmap for CARVYKTI manufacturing in Ghent.
• Support digital projects that improve process robustness, data visibility and efficiency.
• Promote MES best practice and digital manufacturing across the CAR-T network.

Requirements

• A Master's degree in engineering, computer science, life sciences, biotechnology, pharmaceutical sciences or a related field.
• 1-4 years of relevant experience in manufacturing, automation, MES, digital systems, validation or manufacturing support.
• Experience with manufacturing execution systems, preferably Werum PAS-X (highly desirable).
• Experience in GMP-regulated pharmaceutical, biotechnology, cell therapy or biologics manufacturing (preferred).
• Working knowledge of system design, electronic batch records, master data management and qualification.
• Knowledge of computerized system validation (CSV) and GxP requirements.
• Strong analytical and troubleshooting skills for complex technical and process problems.
• Clear communication and effective collaboration with varied stakeholders.
• Able to juggle several priorities and work independently in a demanding manufacturing setting.
• Precise, quality-minded and committed to data integrity.
• Proactive, solution-focused and keen to keep learning and improving.
• Fluent spoken and written English is required; Dutch is a plus.
• Preferred: experience with Werum PAS-X configuration, eBR development or MES deployments.
• Preferred: knowledge of manufacturing in cell therapy, CAR-T, biologics or advanced therapies.
• Preferred: experience supporting integrations with ERP, LIMS, automation or other manufacturing systems.
• Preferred: familiarity with change management, deviation management, CAPA and the validation lifecycle.
• Preferred skills listed: accelerating, communication, detail orientation, execution focus, facility management, GMP, lean manufacturing principles, lean supply chain management, manufacturing engineering, MSAT, problem management, project engineering, project management tools, project support, report writing, safety orientation, STEM application, technical aptitude.

Conditions

The role is based in Ghent, Belgium.

Successful candidates must complete country-specific checks before starting.

The company is an equal opportunity employer that treats each person as an individual.