Senior Lab CSV IT Engineer 1705

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.

Senior Lab CSV IT Engineer 1705

SimoTech is seeking an experienced Senior
Lab CSV IT Engineer to lead and oversee lifecycle management of laboratory
computerised systems for our biopharma client in Co. Cork.

You will partner with a dedicated Project
Manager to plan and deliver a global laboratory systems 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 ensure systems remain validated,
secure, and aligned with applicable regulatory requirements.

Key Responsibilities

• Lead
  planning, execution, and review of CSV deliverables across laboratory systems.
  
• Equipment
  categorisation and task estimation.
  
• Prioritisation
  and tasks and escalation of issues within the team
  
• Managing
  risk and issues and effectively communicating to client stakeholders.
  
• Monitoring
  of deliverables and communication to client stakeholders alongside 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 according to regulatory
  expectations.
  
• Oversee
  system integration with enterprise IT infrastructure and ensure alignment with
  cyber security standards.
  
• Manage
  change control, deviation investigations, and ensure continuous compliance with
  quality systems.
  
• Act as
  SME for internal and external audits, ensuring audit readiness and system
  traceability.
  
• Mentor junior engineers and contribute to knowledge sharing within the
  team.
  
  

Requirements

Qualifications &
Experience

• Bachelor’s degree in Engineering, Computer Science, or a related
  technical discipline.
  
• Minimum 7+ years’ experience in Computer System Validation within
  regulated industries, preferably in GMP laboratory environments.
  
• Expertise in GxP systems, 21 CFR Part 11, data integrity principles, and
  industry best practices.
  
• Strong experience leading CSV projects and delivering compliance
  programs.
  
• In-depth knowledge of lab system integrations and validation of
  high-impact platforms.
  
• Excellent
  leadership, influencing, and stakeholder management skills, with ability to
  mentor and guide teams.
  

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