CAR-T MES Engineer: Driving GMP Manufacturing Excellence

7555-Janssen Pharmaceutica NV Legal Entity; Oost-Vlaanderen; On-site; EUR 60,000 - 96,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Bereavement leave

Well‑being reimbursement

Insurance plans

Job summary

Johnson & Johnson is seeking a MES Engineer for CARVYKTI manufacturing in Ghent to design, validate, and continuously improve PAS‑X MES solutions supporting GMP manufacturing. The role spans master data, lifecycle management, and cross‑functional collaboration to ensure reliable production processes.

You will join the Manufacturing Asset Management (MAM) team, focusing on digital systems, data integrity, and process robustness while enabling life‑changing therapies for patients worldwide.

Qualifications

• Master's degree in Engineering, Computer Science, Life Sciences, Biotechnology, Pharmaceutical Sciences, or a related field is required.
• 2–5 years of experience in manufacturing, automation, MES, digital systems, validation, or manufacturing support functions within regulated environments.
• Hands‑on experience with MES, preferably Werum PAS‑X, including configuration, eBR development, or MES deployments.
• GMP/GxP‑regulated pharmaceutical, biotechnology, cell therapy, biologics, or advanced therapy manufacturing environments and associated processes.
• Strong understanding of system design, eBR, master data management, CSV, qualification, and validation lifecycle activities.
• Experience integrating with ERP, LIMS, automation platforms, and other manufacturing systems, plus change control and CAPA processes.
• Excellent analytical, troubleshooting, problem‑solving, and stakeholder management skills; fluency in English; Dutch is an advantage.

Responsibilities

• MES Design& Configuration: Design, configure, and maintain PAS‑X MES solutions across CARVYKTI production lifecycle.
• Qualification& Validation Support: Support qualification and validation activities; author and review validation docs; coordinate testing with Operations, Quality, Validation, and IT.
• System Support& Issue Resolution: Serve as MES SME; investigate and troubleshoot MES incidents and deviations; contribute to knowledge management and training.
• Master Data& Lifecycle Management: Maintain MES master data; manage data integrity and traceability across MES processes.
• Continuous Improvement& Cross‑Functional Collaboration: Identify opportunities to improve manufacturing efficiency and user experience; support project execution and deployment.
• Strategic Contribution: Contribute to MES roadmap; support digital transformation and best practices across CAR‑T network.

Skills

Analytical Reasoning

Computerized Equipment Skills

Emerging Technologies

Gemba Kaizen

Issue Escalation

Lean Supply Chain Management

Problem Solving

Process Control

Process Engineering

Process Oriented

Product Improvements

Science

Technology

Engineering

Math (STEM) Application

Situational Awareness

Supply Planning

Technical Research

Technologically Savvy

Validation Testing

Education

Master's degree in Engineering, Computer Science, Life Sciences, Biotechnology, Pharmaceutical Sciences, or related field

Tools

Werum PAS‑X

Job description

Johnson & Johnson is seeking a MES Engineer for CARVYKTI manufacturing in Ghent to design, validate, and continuously improve PAS‑X MES solutions supporting GMP manufacturing. The role spans master data, lifecycle management, and cross‑functional collaboration to ensure reliable production processes.

You will join the Manufacturing Asset Management (MAM) team, focusing on digital systems, data integrity, and process robustness while enabling life‑changing therapies for patients worldwide.