CAR-T MES Engineer | PAS-X Expert

Johnson Johnson; Gent; On-site; EUR 60,000 - 96,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Well-being programs

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Analytical thinking

Problem solving

Communication skills

Stakeholder management

English fluent

Education

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

Tools

Werum PAS-X

ERP integration

LIMS

Job description

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.