MES CSV Engineer 1708

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.

• 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.
  

• 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.
  

• 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