MES Engineer

Johnson Johnson; Oost-Vlaanderen; Presencial; EUR 65.000 - 90.000; Jornada completa

Descripción de la vacante

Johnson & Johnson in Ghent is seeking a MES Engineer - PAS-X to design, implement, and uphold PAS-X MES solutions for CARVYKTI production. You will support qualification, validation, and ongoing operations ensuring GMP compliance and data integrity across the CAR-T manufacturing lifecycle.

Join the Manufacturing Asset Management team in Ghent to drive digital transformation, optimize processes, and enable robust MES delivery that supports life-changing therapies worldwide.

Responsabilidades

• Design, configure, and maintain PAS-X MES solutions for CARVYKTI production.
• Support qualification and validation activities with risk assessments and test plans.
• Troubleshoot MES incidents and provide user support to minimize downtime.
• Manage MES master data and lifecycle changes for data integrity.
• Identify opportunities to improve manufacturing efficiency and compliance.
• Contribute to MES roadmap and digital transformation for Ghent CAR-T manufacturing.

Conocimientos

PAS-X MES

MES design

GMP knowledge

Troubleshooting

Herramientas

eBRs

Master data management

Descripción del empleo

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function

Supply Chain Engineering

Job Sub Function

Process Engineering

Job Category

Scientific/Technology

All Job Posting Locations

Gent, East Flanders, Belgium

Job Description

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

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:

1. 1. 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.

2. 2. 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.

3. 3. 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.

4. 4. 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.

5. 5. 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.

6. 6. 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 excelle