MES Engineer

EFOR; Limerick; On-site; EUR 60,000 - 90,000; Full time

Job summary

EFOR is seeking a skilled MES Engineer to join our team in Limerick. The role focuses on deploying and supporting MES solutions for pharmaceutical manufacturing, with emphasis on regulatory compliance and data integrity.

You will configure MES systems, manage recipes and EBRs, and collaborate with Automation, IT, Quality, Production and Engineering to deliver robust MES environments. Validation, audits, and end-user training are key responsibilities.

Qualifications

• Bachelor’s degree or higher in Engineering, Computer Science, Information Systems, or related field.
• 3+ years’ MES experience in GMP-regulated pharma/biotech facility.
• Familiarity with leading MES platforms (PAS-X, Syncade, PharmaSuite, Opcenter).
• Strong understanding of regulatory standards and data integrity.

Responsibilities

• Design, implement and support MES solutions for manufacturing operations in pharma.
• Configure MES systems: recipe management, EBR, data integration, user management.
• Collaborate with Automation, IT, Quality, Production and Engineering teams.
• Lead/root cause analysis and problem resolution for MES issues.
• Ensure validation and compliance with GxP, 21 CFR Part 11, EU Annex 11.
• Produce and maintain URS, FRS, IQ, OQ, PQ validation docs.
• Support audits, inspections and regulatory reviews as required.
• Provide training and technical support to end users.
• Manage system lifecycle: upgrades, patching, change control.

Skills

GxP compliance

Cross-functional collaboration

Validation documentation

Regulatory inspections

Education

Bachelor’s degree or higher in Engineering, Computer Science, Information Systems, or related

Tools

Werum PAS-X

Emerson Syncade

Rockwell PharmaSuite

Siemens Opcenter

Job description

About the Job

Job Description:

We are looking for a skilled Manufacturing Execution Systems (MES) Engineer to join our team in Limerick. The ideal candidate will have hands-on experience in MES deployment and support, with a background in the pharmaceutical industry.

Key Responsibilities:

• Design, implement, and support MES solutions for manufacturing operations, with a strong focus on pharmaceutical industry requirements and regulatory compliance.
• Configure and maintain MES systems, including recipe management, electronic batch records (EBR), data integration, and user management.
• Collaborate with cross-functional teams including Automation, IT, Quality, Production, and Engineering to deliver and maintain robust MES solutions.
• Lead and participate in troubleshooting, root cause analysis, and problem resolution for MES-related issues.
• Ensure system validation and compliance with GxP, 21 CFR Part 11, EU Annex 11, and data integrity guidelines.
• Produce, review, and manage validation documentation (URS, FRS, IQ, OQ, PQ) for MES components.
• Support site audits, inspections, and regulatory reviews as required.
• Provide training and technical support to end users and stakeholders.
• Manage system lifecycle activities, including upgrades, patching, and change control.

Requirements:

• Bachelor’s degree or higher in Engineering, Computer Science, Information Systems, or a related discipline.
• Minimum of 3 years’ experience working as an MES Engineer in a GMP-regulated pharmaceutical or biotechnology facility.
• Strong familiarity with leading MES platforms (e.g., Werum PAS-X, Emerson Syncade, Rockwell PharmaSuite, Siemens Opcenter, or similar).
• Proven understanding of pharmaceutical manufacturing processes, regulatory standards, and data integrity principles.
• Experience preparing and executing validation deliverables and supporting regulatory inspections.