MES Engineer

JOB SUMMARY

CAR‑T is an innovative treatment that harnesses the power of a patient's own immune system. By genetically modifying a patient's T-cells to target and destroy cancer cells, this breakthrough technology offers new hope to patients for whom conventional therapies no longer provide adequate results. Join our innovative team within the Manufacturing Asset Management (MAM) organization in Ghent as a MES Engineer supporting the PAS‑X Manufacturing Execution System (MES) for CARVYKTI manufacturing. In this role, you will play a key part in designing, maintaining, qualifying, and continuously improving MES solutions that support GMP manufacturing operations and ensure the reliable execution of critical production processes. This is a unique opportunity to develop expertise at the intersection of cell therapy manufacturing, digital systems, and operational excellence while contributing directly to the delivery of life‑changing treatments to patients worldwide.

As a MES Engineer – PAS‑X, your main responsibilities include:

RESPONSIBILITIES

MES Design & Configuration

• Design, configure, and maintain PAS‑X MES solutions to support manufacturing processes across the CARVYKTI production lifecycle.
• Translate business and operational requirements into compliant MES designs and system enhancements.
• Develop and maintain electronic batch records (eBRs), workflows, master data, and system configurations.
• Ensure MES solutions remain aligned with evolving business needs, GMP requirements, and site standards.

Qualification & Validation Support

• Support qualification and validation activities for MES deployments, enhancements, and periodic updates.
• Author and review validation documentation, including requirements, risk assessments, test protocols, and summary reports.
• Coordinate testing activities with Operations, Quality, Validation, and IT stakeholders.
• Ensure all MES changes are implemented in accordance with applicable quality and compliance requirements.

System Support & Issue Resolution

• Serve as a technical MES subject matter expert and support manufacturing operations in the resolution of system-related issues.
• Investigate and troubleshoot MES incidents, deviations, and system events to minimize operational impact.
• Contribute to knowledge management, user training, and support documentation to strengthen operational readiness.

Master Data & Lifecycle Management

• Maintain oversight of MES master data, ensuring accuracy, consistency, and compliance throughout the system lifecycle.
• Support controlled deployment of process updates, recipes, materials, equipment models, and workflow modifications.
• Ensure data integrity and traceability across MES processes and integrations.
• Participate in system lifecycle activities, including upgrades, patching, and platform improvements.

Continuous Improvement & Cross‑Functional Collaboration

• Identify opportunities to improve manufacturing efficiency, compliance, and user experience through MES enhancements.
• Support project execution and change implementation activities from requirements gathering through deployment.
• Foster a culture of innovation, continuous improvement, and operational excellence within the CAR‑T manufacturing environment.

Strategic Contribution

• Contribute to the evolution of the MES roadmap supporting CARVYKTI manufacturing in Ghent.
• Support digital transformation initiatives aimed at improving process robustness, data visibility, and manufacturing efficiency.
• Act as a key advocate for MES best practices and digital manufacturing excellence across the CAR‑T network.

QUALIFICATIONS

A Master's degree in Engineering, Computer Science, Life Sciences, Biotechnology, Pharmaceutical Sciences, or a related field is required.

Experience and Expertise

• 1-4 years of relevant experience in manufacturing, automation, MES, digital systems, validation, or manufacturing support functions.
• Experience with Manufacturing Execution Systems (MES), preferably Werum PAS‑X, is highly desirable.
• Experience working in GMP‑regulated pharmaceutical, biotechnology, cell therapy, or biologics manufacturing environments is preferred.
• Familiarity with system design, electronic batch records, master data management, and qualification activities.
• Knowledge of computerized system validation (CSV) and GxP requirements.
• Strong analytical and troubleshooting skills with the ability to investigate complex technical and process‑related issues.
• Excellent communication skills and ability to collaborate effectively with diverse stakeholders.
• Ability to manage multiple priorities and work independently in a fast‑paced manufacturing