Senior Labs CSV IT Engineer 1705

SimoTechnology; Cork; On-site; EUR 85,000 - 120,000; Full time

Job summary

SimoTech in Cork is seeking an experienced Senior Lab CSV IT Engineer to lead lifecycle management of laboratory computerised systems for a biopharma client. You will partner with a Project Manager to plan and deliver a global program focused on harmonization, process improvement, and compliance.

You will provide technical leadership for CSV activities, support validation and compliance initiatives, and work with cross-functional teams to keep systems validated, secure, and aligned with

Qualifications

• Bachelor’s degree in Engineering, Computer Science, or related technical discipline.
• 7+ years’ experience in Computer System Validation within regulated industries (GMP).
• Expertise in GxP, 21 CFR Part 11, data integrity principles, and industry best practices.
• Strong experience leading CSV projects and delivering compliance programs.

Responsibilities

• Lead planning, execution, and review of CSV deliverables across laboratory systems.
• Equipment categorisation and task estimation.
• Prioritisation and escalation of issues within the team.
• Managing risk and issues and communicating with client stakeholders.
• Monitoring of deliverables and communication to client stakeholders with the Project Manager.
• Provide technical direction on validation strategies and risk assessments for new and existing systems.
• Generate and approve SDLC documentation and validation protocols per regulatory expectations.
• Oversee system integration with enterprise IT infrastructure and ensure alignment with cyber security standards.
• Manage change control, deviation investigations, and ensure continuous quality system compliance.
• Act as SME for internal and external audits, ensuring audit readiness and system traceability.
• Mentor junior engineers and contribute to knowledge sharing.

Skills

CSV experience

Leadership

Stakeholder management

Regulatory compliance

GxP

SDLC documentation

Education

Bachelor’s degree in Engineering, Computer Science, or related technical discipline

Tools

Validation tools

Job description

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.

Key Responsibilities

• 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.
  

Requirements

Qualifications &Experience

• 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.
  

What SimoTech CanOffer

• 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