MES Validation Engineer

SimoTech; Cork; On-site; EUR 60,000 - 90,000; Full time

Job summary

SimoTech in Cork is seeking an experienced MES Validation Engineer to support a paper-to-digital MES implementation project. You will validate Digital Batch Records (EBRs/MBRs), perform testing, validation, and interface verification with third-party systems in a GMP environment.

The role focuses on designing and executing test scripts, reviewing design specs, ensuring GMP and GAMP 5 compliance, and collaborating with MES developers, automation engineers, Quality, and IT to deliver a compliant

Qualifications

• Degree in Engineering, Computer Science, Life Sciences, or related discipline.
• 3+ years in Computer System Validation within a GMP manufacturing environment.
• Strong experience with Syncade MES testing and validation.
• Solid knowledge of GxP and GAMP 5 guidelines for MES systems and integrations.
• Proven expertise in writing and executing test scripts, managing deviations, and compiling validation reports.
• Familiarity with interface testing between MES and external systems (ERP, automation, or historians).
• Excellent attention to detail and strong documentation skills.

Responsibilities

• Develop and execute test scripts and validation protocols for MES recipes (EBRs/MBRs), workflows, and system configurations in Syncade.
• Perform interface testing between Syncade MES and integrated third-party systems (e.g., automation platforms, ERP).
• Review and approve design specifications to ensure alignment with user requirements and GMP compliance.
• Document and manage test evidence, deviations, and validation deliverables in accordance with CSV and site quality standards.
• Support User Acceptance Testing (UAT) and participate in issue resolution during qualification and deployment phases.
• Ensure compliance with GMP, GAMP 5, and regulatory requirements for MES validation activities.
• Collaborate with cross-functional teams including MES developers, automation engineers, Quality, and IT to deliver a robust and compliant digital batch solution.

Skills

CSV validation

Test scripting

Documentation

Interface testing

GxP knowledge

Education

Engineering degree

Computer Science degree

Life Sciences degree

Tools

Syncade MES

Job description

SimoTech provides manufacturing automation and IT systems engineering, project management and validation services. We partner with life sciences companies to design, build, operate and optimise critical process automation systems that deliver fast track project delivery, operational efficiency, improve manufacturing agility and achieve regulatory compliance.

Why SimoTech

What is it like to work at SimoTech? With a strong collaborative teamwork culture based on respect, trust and excellence, we play a critical partnering role to our clients’ life-changing supply of products to patients. In return, there is excellent salary, benefits, career progression, educational support and much more.

SimoTech has an exciting opportunity for an experienced MES Validation Engineer to support a paper-to-digital MES implementation project in Cork. This project involves delivering Digital Batch Records (EBRs/MBRs) on MES, including testing, validation, and interface verification with third-party systems.

The ideal candidate will play a key role as the project transitions into the design approval and testing phases, working within a cross-functional team to verify workflows, recipes, and system integrations in a regulated GMP environment. This role offers an excellent opportunity to combine your validation expertise with exposure to advanced MES technologies and digital manufacturing transformation.

Key Responsibilities

• Develop and execute test scripts and validation protocols for MES recipes (EBRs/MBRs), workflows, and system configurations in Syncade.
• Perform interface testing between Syncade MES and integrated third-party systems (e.g., automation platforms, ERP).
• Review and approve design specifications to ensure alignment with user requirements and GMP compliance.
• Document and manage test evidence, deviations, and validation deliverables in accordance with CSV and site quality standards.
• Support User Acceptance Testing (UAT) and participate in issue resolution during qualification and deployment phases.
• Ensure compliance with GMP, GAMP 5, and regulatory requirements for MES validation activities.
• Collaborate with cross-functional teams including MES developers, automation engineers, Quality, and IT to deliver a robust and compliant digital batch solution.

Key Requirements

• Degree in Engineering, Computer Science, Life Sciences, or related discipline.
• 3+ years’ experience in Computer System Validation (CSV) within a GMP-regulated manufacturing environment.
• Strong hands-on experience with Syncade MES testing and validation, including EBR development and workflow approval.
• Solid knowledge of GxP and GAMP 5 guidelines for MES systems and integrations.
• Proven expertise in writing and executing test scripts, managing deviations, and compiling validation reports.
• Familiarity with interface testing between MES and external systems (ERP, automation, or historians).
• Excellent attention to detail and strong documentation skills.