GxP Lab IT Specialist — End-to-End Support & Compliance

HCL Technologies Limited

Dunboyne

On-site

EUR 55,000 - 85,000

Full time

6 days ago
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Job summary

HCL Technologies Limited in Ireland seeks a Lab IT Administrator to deliver end-to-end support for lab users and stakeholders. You will manage lab IT systems, assist with validation and documentation, and ensure regulatory compliance across 21 CFR Part 11 and EU Annex 11.

The role requires strong communication and multi-tasking in a regulated environment. You will work with the Lab COE and local site DMO, coordinate with support teams, and contribute to inspections and readiness activities,

Qualifications

  • Bachelor’s degree in a technical discipline is required.
  • Minimum 5+ years of professional experience in the digital space.
  • Excellent written and oral communication skills.
  • Ability to multi-task with competing priorities and lead documentation efforts.

Responsibilities

  • Provide hands-on end user support and admin for GxP lab equipment, servers, desktops and software.
  • Troubleshoot complex lab IT issues across software, OS, hardware, network and interfaces.
  • Execute routine system administration and maintenance tasks.
  • Maintain user management for all computerized systems.
  • Author validation, qualification and testing documents (IQ/OQ/PQ, etc.).
  • Ensure 21 CFR Part 11 and EU Annex 11 compliance and data integrity standards.
  • Collaborate with CSV Lead, System Integrator and Site IT Team.
  • Assist with inspections and operational readiness activities.
  • Provide SME guidance for troubleshooting and problem solving.
  • Create backups and respond to help desk requests.

Skills

End user support
Documentation
Regulatory compliance
GxP familiarity
Problem solving

Education

Bachelor’s Degree in a technical discipline

Tools

21 CFR Part 11
Data Integrity
System validation
GxP lab systems

Job description

HCL Technologies Limited in Ireland seeks a Lab IT Administrator to deliver end-to-end support for lab users and stakeholders. You will manage lab IT systems, assist with validation and documentation, and ensure regulatory compliance across 21 CFR Part 11 and EU Annex 11.

The role requires strong communication and multi-tasking in a regulated environment. You will work with the Lab COE and local site DMO, coordinate with support teams, and contribute to inspections and readiness activities,

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