MES Validation Engineer 1707
Posted 3 days 1 hour ago by SimoTech
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.
- 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.
- 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.
- 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