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. 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. 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. 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. 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. 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. 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
Education
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 environment.
Strong attention to detail, quality mindset, and commitment to data integrity.
Proactive, solution-oriented, and eager to continuously learn and improve.
Fluency in spoken and written English is required; Dutch is a plus.
Preferred
Experience with Werum PAS-X configuration, eBR development, or MES deployments.
Knowledge of manufacturing processes within cell therapy, CAR-T, biologics, or advanced therapies.
Experience supporting system integrations with ERP, LIMS, automation, or other manufacturing systems.
Familiarity with change management, deviation management, CAPA processes, and validation lifecycle activities.
At Johnson & Johnson, we want every candidate to feel supported throughout the hiring process. Our goal is to make the experience clear, fair, and respectful of your time.
Here’s what you can expect
Application review: We’ll carefully review your CV to see how your skills and experience align with the role.
Getting to know you: If there’s a good match, you’ll be invited to a short call with one of our recruitment team to understand more about you and answer any questions that you might have.
Staying informed: We know waiting can be hard and processes can evolve; our recruitment team will keep you updated and make sure you know what to expect at each step.
Final steps: For successful candidates, you will need to complete country-specific checks before starting your new role. We will help guide you through these.
Finally, at the end of the process, we’ll invite you to share feedback in a short survey — your input helps us continue improving the experience for future candidates. Thank you for considering a career with Johnson & Johnson. We’re excited to learn more about you and wish you the best of luck in the process! #RPOEMEA
Required Skills
Preferred Skills
Accelerating, Communication, Detail-Oriented, Execution Focus, Facility Management, Good Manufacturing Practices (GMP), Lean Manufacturing Principles, Lean Supply Chain Management, Manufacturing Engineering, Manufacturing Science and Technology (MSAT), Problem Management, Project Engineering, Project Management Tools, Project Support, Report Writing, Safety-Oriented, Science, Technology, Engineering, and Math (STEM) Application, Technologically Savvy
