MES Engineer

Johnson Johnson; Gent; Vor Ort; EUR 60.000 - 96.000; Vollzeit

Benefits dieser Stelle

Annual bonus

Vacation days

Parental leave

Well-being programs

Zusammenfassung

Johnson & Johnson in Ghent is seeking a MES Engineer - PAS-X to design, configure, and maintain PAS-X MES solutions across the CARVYKTI production lifecycle. You will join the Manufacturing Asset Management (MAM) group and help ensure GMP manufacturing processes run reliably.

The role focuses on MES design, validation, data integrity, and cross-functional collaboration to drive continuous improvement in a cutting-edge cell therapy environment.

Qualifikationen

• Master's degree in engineering, computer science, life sciences, biotechnology, pharmaceutical sciences, or related field.
• 2-5 years of experience in manufacturing, automation, MES, digital systems, validation, or manufacturing support in 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 and related processes.
• Strong design, electronic batch records, master data management, CSV, qualification and validation lifecycle understanding.
• Experience with system integrations with ERP, LIMS, automation platforms, and CAPA processes.
• Fluent English; Dutch is an advantage.

Aufgaben

• 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 GMP requirements and site standards.
• 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 quality and compliance requirements.
• Serve as a MES subject matter expert and support manufacturing operations in issue resolution.
• Investigate MES incidents, deviations, and system events to minimize operational impact.
• Contribute to knowledge management, user training, and support documentation to strengthen operational readiness.
• Maintain oversight of MES master data, ensuring accuracy and traceability throughout the lifecycle.
• Participate in system lifecycle activities, including upgrades, patching, and platform improvements.
• Identify opportunities to improve manufacturing efficiency and data visibility; support cross-functional projects.

Kenntnisse

Analytical thinking

Problem solving

Communication skills

Stakeholder management

English fluent

Ausbildung

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

Tools

Werum PAS-X

ERP integration

LIMS

Jobbeschreibung

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. 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.

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.

Required Skills:

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.