MES CSV Engineer 1708

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

Benefits offered by this job

Competitive salary

Benefits

Educational support

Job summary

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

The role collaborates with MES developers, automation, Quality and IT, validating workflows, recipes, and system integrations, contributing to regulatory compliance and a robust digital batch solution.

Qualifications

• 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.
• Ability to work effectively in a hybrid setting and engage with multiple project stakeholders.

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., 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.
• 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

Attention to detail

Documentation

Cross-functional collaboration

Problem solving

Education

Engineering, Computer Science, Life Sciences or related

Tools

Syncade MES

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 excitingopportunity for an experiencedMES Validation Engineerto supportadigital MES implementation projectbased in Co. Limerick. Thisproject involves deliveringDigital Batch Records(EBRs/MBRs) on MES,including testing, validation, and interface verification with third-partysystems.

The ideal candidate will play a keyrole as the project transitions into thedesign approval and testingphases, working within a cross-functional team to verify workflows, recipes,and system integrations in a regulated GMP environment. This role offers anexcellent opportunity to combine your validation expertise with exposure toadvanced MES technologies and digital manufacturing transformation.

Key Responsibilities

• Develop and executetest scripts and validation protocolsforMES recipes (EBRs/MBRs), workflows, and system configurations in Syncade.
  
• Performinterface testingbetween Syncade MES and integratedthird-party systems (e.g., automation platforms, ERP).
  
• Review and approvedesign specificationsto ensure alignmentwith user requirements and GMP compliance.
  
• Document and managetest evidence, deviations, and validationdeliverablesin accordance with CSV and site quality standards.
  
• SupportUser Acceptance Testing (UAT)and participate in issueresolution during qualification and deployment phases.
  
• Ensure compliance withGMP, GAMP 5, and regulatory requirements forMES validation activities.
  
• Collaborate with cross-functional teams including MES developers,automation engineers, Quality, and IT to deliver a robust and compliant digitalbatch 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.
  
• Ability to work effectively in a hybrid setting and engage with multipleproject stakeholders.
  

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