MES Validation Engineer 1707

Simotechnology; Cork; On-site; EUR 70,000 - 98,000; Full time

Benefits offered by this job

Autonomy

Skills development

Major clients

Job summary

SimoTech is seeking an experienced MES Validation Engineer to support a paper-to-digital MES implementation in Cork. You will validate digital batch records, test interfaces with third-party systems, and verify workflows in a GMP environment.

The role involves developing and executing validation scripts, reviewing specs, and ensuring regulatory compliance, with opportunities to work across cross-functional teams in a growing digital manufacturing project.

Qualifications

• 3+ years’ experience in Computer System Validation (CSV) within a GMP-regulated manufacturing environment.
• 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.

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 (ERP, automation).
• Review and approve design specifications to ensure alignment with user requirements and GMP compliance.
• Document and manage test evidence, deviations, and validation deliverables per CSV and site standards.
• Support 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 MES developers, automation engineers, Quality, and IT to deliver a robust digital batch solution.

Skills

Attention to detail

Test scripting

Cross-functional collaboration

Education

Engineering / Computer Science / Life Sciences degree

Tools

Syncade MES testing

Job description

Whatis it like to work at SimoTech? With a strong collaborative teamworkculture based on respect, trust, and excellence, we play a criticalpartnering role to our clients’ life-changing supply of products topatients. In return, there is excellent salary, benefits, careerprogression, educational support andmuch more.

SimoTech has an exciting opportunity for an experiencedMES Validation Engineerto support apaper-to-digital MES implementation projectin Cork. This project involves deliveringDigital 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 thedesign 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 executetest scripts and validation protocolsfor MES recipes (EBRs/MBRs), workflows, and system configurations in Syncade .
  
• Performinterface testingbetween Syncade MES and integrated third-party systems (e.g., automation platforms, ERP).
  
• Review and approvedesign specificationsto ensure alignment with user requirements and GMP compliance.
  
• Document and managetest evidence, deviations, and validation deliverablesin accordance withCSV and site quality standards.
  
• SupportUser Acceptance Testing (UAT)andparticipatein issue resolution during qualification and deployment phases.
  
• Ensure compliance withGMP, 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.
  

Requirements

Qualifications &Experience

• Degree inEngineering, Computer Science, Life Sciences, or relateddiscipline.
  
• 3+ years’ experience inComputer System Validation(CSV)within a GMP-regulated manufacturing environment.
  
• Strong hands-on experience withSyncade MES testing and validation,including EBR development and workflow approval.
  
• Solid knowledge ofGxP and GAMP 5 guidelinesfor MES systemsand integrations.
  
• Proven expertise in writing and executing test scripts, managingdeviations, and compiling validation reports.
  
• Familiarity withinterface testing between MES and externalsystems(ERP, automation, or historians).
  
• Excellent attention to detail and strong documentation skills.
  

What SimoTech CanOffer

• Role provides ahigh degree of autonomy to allow the successfulcandidate to reach their fullpotential.
  
• Develop newskills and enhance technical ability by working withinnovative technologies in a multi- disciplinedenvironment.
  
• Opportunity towork with large corporate clients