CAR-T MES Engineer (PAS-X) – GMP Manufacturing

Johnson & Johnson Innovative Medicine; Oost-Vlaanderen; On-site; EUR 60,000 - 96,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Job summary

Johnson & Johnson Innovative Medicine is seeking a MES Engineer – PAS-X to design, implement, and sustain PAS-X MES solutions for CARVYKTI manufacturing in Ghent. You will work across QA, IT, Operations to ensure compliant MES deployments and maintain eBRs and master data.

Role emphasizes GMP compliance, data integrity, and continuous improvement within a regulated cell therapy environment. English fluency is required; Dutch is a plus.

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 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 and processes.
• Strong understanding of system design, eBR, master data, 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 ability to manage multiple priorities and maintain quality and data integrity.
• Strong communication and stakeholder management skills; English required; Dutch advantageous.

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 GMP requirements and site standards.
• Support qualification and validation activities for MES deployments, enhancements, and updates.
• Coordinate testing activities with Operations, Quality, Validation, and IT stakeholders.
• Investigate MES incidents, deviations, and system events to minimize impact.
• Maintain MES master data and participate in lifecycle activities including upgrades.

Skills

PAS-X MES

eBR/DOCS

CSV

Master Data

CAPA

ERP Integration

LIMS

GxP Compliance

Analytical Skills

Stakeholder Mgmt

English Proficiency

Education

Master’s degree in Engineering/Sciences/Pharma

Tools

PAS-X

Job description

Johnson & Johnson Innovative Medicine is seeking a MES Engineer – PAS-X to design, implement, and sustain PAS-X MES solutions for CARVYKTI manufacturing in Ghent. You will work across QA, IT, Operations to ensure compliant MES deployments and maintain eBRs and master data.

Role emphasizes GMP compliance, data integrity, and continuous improvement within a regulated cell therapy environment. English fluency is required; Dutch is a plus.