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SimoTech is an engineering consultancy firm that provides specialized automation, IT, and project management services to external clients in the life sciences and pharmaceutical sectors, with this position explicitly involving onsite support for a client.

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S
Posted 3w ago

MES Validation Engineer 1707

SimoTech
View all open roles
Cork, Munster, Ireland
OnsiteFull Time
Responsibilities
  • developing tests
  • performing interface-testing
  • documenting evidence
Requirements
  • Degree in engineering/computer science/life sciences,3+ years CSV experience in GMP environments,Syncade MES validation experience,knowledge of GxP/GAMP5,testing and documentation skills
Technical tools mentioned
SyncadeERP

Job description


Why SimoTech



What
is it like to work at SimoTech? With a strong collaborative teamwork
culture based on respect, trust, and excellence, we play a critical
partnering role to our clients’ life-changing supply of products to
patients.  In return, there is excellent salary, benefits, career
progression, educational support and much more.




MES Validation Engineer 1707


SimoTech has an exciting opportunity for an experienced MES Validation Engineer to support a paper-to-digital MES implementation project in Cork. This project involves delivering Digital 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 the design 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 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.



Requirements

Qualifications &
Experience

  • 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.


Benefits

What SimoTech Can
Offer

  • Role provides a
    high degree of autonomy to allow the successful
    candidate to reach their full
    potential.
  • Develop new
    skills and enhance technical ability by working with
    innovative technologies in a multi- disciplined
    environment.
  • Opportunity to
    work with large corporate clients