MES Validation Engineer: Digital Batch & GMP Specialist

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 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