MES Engineer CAR-T

Biopharma Careers; Oost-Vlaanderen; Sur place; EUR 52 000 - 83 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Vacation days

Parental leave

Well-being reimbursement

Insurance plans

Service awards

Résumé du poste

Johnson & Johnson in Gent, Belgium is seeking an MES Engineer to support PAS-X MES for CARVYKTI manufacturing. You will design, implement, qualify, and maintain MES solutions ensuring GMP compliance and robust data integrity across the CAR-T production lifecycle.

You will collaborate with Operations, Quality, Validation, and IT teams to drive continuous improvement, resolve system incidents, and manage master data and lifecycle activities for MES deployments.

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.
• Knowledge of GMP/GxP-regulated pharmaceutical, biotechnology, cell therapy, biologics, or advanced therapy manufacturing environments.

Responsabilités

• 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.

Connaissances

MES

PAS-X

GMP

CSV

Stakeholder mgmt

Formation

Master's degree in Engineering or related

Outils

Werum PAS-X

Description du poste

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

Manufacturing Engineering

Job Category

Scientific/Technology

All Job Posting Locations

Gent, East Flanders, Belgium

Job Description

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.

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

• 2-5 years of experience in manufacturing, automation, MES, digital systems, validation, or manufacturing support functions within regulated environments.
• Hands-on experience with Manufacturing Execution Systems (MES), preferably Werum PAS-X, including configuration, eBR development, or MES deployments.
• Knowledge of GMP/GxP-regulated pharmaceutical, biotechnology, cell therapy, biologics, or advanced therapy manufacturing environments and associated manufacturing processes.
• Strong understanding of system design, electronic batch records (eBR), master data management, computerized system validation (CSV), qualification, and validation lifecycle activities.
• Experience supporting system integrations with ERP, LIMS, automation platforms, and other manufacturing systems, along with change control, deviation management, and CAPA processes.
• Excellent analytical, troubleshooting, and problem-solving skills, with the ability to manage multiple priorities, work independently, and maintain a strong focus on quality and data integrity.
• Strong communication and stakeholder management skills, with a proactive, continuous improvement mindset; fluency in English is required and Dutch is an advantage.

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

Salary

€52.000,00 - €82.685,00

Benefits

• In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions.
• Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health.
• We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans.
• For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.
• *This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.