CSV/MES ENGINEER

EFOR; Limerick; On-site; EUR 65,000 - 90,000; Full time

Job summary

EFOR is seeking an experienced MES Engineer to join a growing team focused on designing, implementing, and enhancing MES solutions in a regulated manufacturing setting. The role involves working with cross-functional teams to digitalize processes, improve efficiency, and support continuous improvement initiatives.

Key responsibilities include transitioning to electronic batch records, developing MES workflows, and ensuring GMP/CSV compliance.

Qualifications

• Bachelor's degree or higher in a relevant field.
• Experience with MES platforms (PAS-X, Syncade, PharmaSuite) is advantageous.
• Knowledge of GMP, CSV and GxP compliance.
• Strong problem-solving and communication skills.

Responsibilities

• Evaluate paper-based production processes and transition to electronic batch records within MES.
• Design, configure, and develop electronic batch records and MES workflows.
• Enhance and maintain MES applications including EBRs, weigh & dispense, equipment tracking.
• Provide ongoing support, troubleshooting, and issue resolution for MES applications.
• Participate in design reviews ensuring requirements are traceable.
• Develop reusable MES components and templates for consistency.
• Support CSV documentation and GMP compliance; participate in audits.

Skills

MES expertise

VB scripting

MES troubleshooting

Analytical skills

Requirements gathering

Automation systems

GMP/CSV

Communication

Learning agility

Continuous improvement

Education

Bachelor's degree in Computer Science/Engineering/IT

Tools

PAS-X

Syncade

PharmaSuite

Job description

We are seeking an experienced MES Engineer to join a growing team supporting the design, implementation, and ongoing enhancement of Manufacturing Execution System (MES) solutions within a regulated manufacturing environment. This role offers the opportunity to work closely with cross-functional teams to digitalize manufacturing processes, improve operational efficiency, and support continuous improvement initiatives.

Key Responsibilities

• Collaborate with manufacturing and business stakeholders to evaluate paper-based production processes and develop strategies for transitioning to electronic batch records (EBRs) within the MES platform.
• Participate in process mapping and requirements gathering to support solution design and implementation.
• Design, configure, and develop electronic batch records and MES workflows.
• Enhance and maintain existing MES applications, including electronic batch records, weigh and dispense, and equipment tracking functionality.
• Provide ongoing support, troubleshooting, and issue resolution for MES applications.
• Participate in design reviews to ensure requirements are fully traceable throughout the project lifecycle.
• Develop reusable MES components and templates to promote consistency and efficiency across multiple manufacturing processes.
• Prepare, execute, review, and support computer system validation (CSV) documentation in accordance with GMP requirements.
• Identify opportunities for continuous improvement within MES processes and applications.
• Keep up to date with emerging MES technologies, industry standards, and best practices.
• Monitor system performance and key operational metrics, reporting findings to project and governance teams.
• Provide technical guidance and subject matter expertise to colleagues and project teams.
• Mentor junior team members and contribute to knowledge sharing across the MES function.
• Support integrations between MES and other manufacturing systems, including ERP, SCADA/DCS, and Plant Historians.
• Participate in internal and external audits, supporting compliance activities as required.
• Support investigations into MES-related deviations and implement corrective actions where appropriate.
• Develop and maintain technical documentation, training materials, and knowledge base articles.
• Build strong relationships with manufacturing, quality, engineering, and IT stakeholders to deliver reliable MES solutions.

Required Skills & Experience

• Experience developing or configuring Manufacturing Execution Systems (MES) within a regulated manufacturing environment.
• Knowledge of object-oriented programming concepts with practical experience in Visual Basic scripting or similar technologies.
• Experience implementing, supporting, and troubleshooting MES or comparable manufacturing applications.
• Strong analytical and problem-solving skills with the ability to work independently and collaboratively.
• Experience gathering business requirements and translating them into technical solutions.
• Good understanding of manufacturing automation systems, including DCS, SCADA, Plant Historians, and ERP integrations (e.g., SAP).
• Working knowledge of GMP regulations, Computer System Validation (CSV), and GxP compliance.
• Excellent written and verbal communication skills with the ability to engage both technical and non-technical stakeholders.
• Demonstrated ability to learn new technologies, processes, and business applications quickly.
• Proactive approach to continuous improvement, relationship building, and issue resolution.

Qualifications

• Bachelor's degree in Computer Science, Engineering, Information Technology, or a related discipline.
• Relevant MES platform experience (e.g., PAS-X, Syncade, PharmaSuite, or similar) is advantageous.