MES Engineer

jj; Oost-Vlaanderen; Sur place; EUR 60 000 - 96 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Vacation days

Parental leave

Well-being reimbursement

Résumé du poste

Johnson & Johnson is seeking an MES Engineer – PAS-X to design, implement, and maintain PAS-X MES solutions for CARVYKTI manufacturing in Ghent. You will work on eBRs, master data, and system configurations to ensure GMP-compliant operations.

The role emphasizes qualification, validation, troubleshooting, and continuous improvement in a fast-paced, technically advanced CAR-T manufacturing environment.

Qualifications

• Master's degree in Engineering, Computer Science, Life Sciences, Biotechnology, Pharmaceutical Sciences, or related field.
• 2-5 years of experience in regulated manufacturing environments.
• Hands-on MES experience, preferably Werum PAS-X, including configuration or eBR development.
• GMP/GxP knowledge and validated lifecycle experience.
• Fluency in English; Dutch is an advantage.

Responsabilités

• Design, configure, and maintain PAS-X MES solutions to support CARVYKTI production lifecycle.
• Support qualification and validation activities for MES deployments and updates.
• Investigate and resolve MES incidents, deviations, and system events.
• Maintain MES master data and lifecycle management across deployments.
• Identify opportunities for continuous improvement and cross-functional collaboration.
• Contribute to the MES roadmap for CAR-T manufacturing in Ghent.

Connaissances

PAS-X MES

GMP knowledge

Validation lifecycle

English fluency

Analytical thinking

Formation

Master's degree (Engineering/ sciences)

Outils

PAS-X

Description du poste

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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.

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.

• 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.

*There is a pre-identified candidate for this position*

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:

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, and Math (STEM) Application, Situational Awareness, Supply Planning, Technical Research, Technologically Savvy, Validation Testing

Preferred 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, and Math (STEM) Application, Situational Awareness, Supply Planning, Technical Research, Technologically Savvy, Validation Testing

The anticipated base pay range for this position is:

€60.000,00 - €96.255,00

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.