MES CSV Engineer 1708

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 CSV Engineer 1708

SimoTech has an exciting
opportunity for an experienced MES Validation Engineer to support
a digital MES implementation project based in Co. Limerick. 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.
  
• Ability to work effectively in a hybrid setting and engage with multiple
  project stakeholders.
  

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