Senior Lab CSV IT Engineer 1705

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 is seeking an experienced SeniorLab CSV IT Engineer to lead and oversee lifecycle management of laboratorycomputerised systems for our biopharma client in Co. Cork.

You will partner with a dedicated ProjectManager to plan and deliver a global laboratory systems program focused onharmonization, process improvement, and compliance. You will provide technicalleadership for CSV activities, support validation and compliance initiatives,and work with cross-functional teams to ensure systems remain validated,secure, and aligned with applicable regulatory requirements.

• Leadplanning, execution, and review of CSV deliverables across laboratory systems.
  
• Equipmentcategorisation and task estimation.
  
• Prioritisationand tasks and escalation of issues within the team
  
• Managingrisk and issues and effectively communicating to client stakeholders.
  
• Monitoringof deliverables and communication to client stakeholders alongside the ProjectManager.
  
• Providetechnical direction on validation strategies and risk assessments for new andexisting systems.
  
• Generateand approve SDLC documentation and validation protocols according to regulatoryexpectations.
  
• Overseesystem integration with enterprise IT infrastructure and ensure alignment withcyber security standards.
  
• Managechange control, deviation investigations, and ensure continuous compliance withquality systems.
  
• Act asSME for internal and external audits, ensuring audit readiness and systemtraceability.
  
• Mentor junior engineers and contribute to knowledge sharing within theteam.
  

• Bachelor's degree in Engineering, Computer Science, or a relatedtechnical discipline.
  
• Minimum 7+ years' experience in Computer System Validation withinregulated industries, preferably in GMP laboratory environments.
  
• Expertise in GxP systems, 21 CFR Part 11, data integrity principles, andindustry best practices.
  
• Strong experience leading CSV projects and delivering complianceprograms.
  
• In-depth knowledge of lab system integrations and validation ofhigh-impact platforms.
  
• Excellentleadership, influencing, and stakeholder management skills, with ability tomentor and guide teams.
  

• 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