GMP Lab IT & CSV Engineer | Hybrid Cork

Catalyx

Cork

Hybrid

EUR 60,000 - 75,000

Full time

3 days ago
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Job summary

Catalyx is seeking a CSV Engineer to join our team on a major pharmaceutical project in Cork. The role focuses on laboratory IT systems, validation, documentation, and cross-functional project support within a GMP-regulated environment.

You will collaborate with QC, IT, engineering and project teams to ensure systems stay compliant, reliable and aligned with regulatory and data integrity requirements. Hybrid position across site activities.

Qualifications

  • Degree in IT, Computer Science, BIS, Chemistry, Biology or related discipline.
  • Experience with GMP or regulated laboratory environments is advantageous.
  • Strong troubleshooting and problem-solving skills.
  • Excellent communication and stakeholder management.
  • Ability to work independently and within cross-functional teams.

Responsibilities

  • Support delivery of laboratory systems projects within a GMP-regulated QC environment.
  • Collaborate with site teams on system requirements, configurations and IOQ documentation.
  • Author, review and approve validation and lifecycle documentation for laboratory systems.
  • Assist with risk assessments related to laboratory systems and processes.
  • Support deployment, configuration and end-user training for QC lab IT systems.
  • Troubleshoot and maintain reliability of QC laboratory IT systems.
  • Work cross-functionally with QC, IT, engineering, validation and project stakeholders.
  • Ensure GMP, data integrity and regulatory compliance including 21 CFR Part 11.
  • Contribute to continuous improvement within the laboratory systems environment.
  • Maintain strong documentation practices and high compliance standards.

Skills

Communication
Problem solving
Independent working
Cross-functional collaboration

Education

Degree in IT, Computer Science, BIS, Chemistry, Biology or related discipline

Tools

Windows 10/11
Server environments
CSV

Job description

Catalyx is seeking a CSV Engineer to join our team on a major pharmaceutical project in Cork. The role focuses on laboratory IT systems, validation, documentation, and cross-functional project support within a GMP-regulated environment.

You will collaborate with QC, IT, engineering and project teams to ensure systems stay compliant, reliable and aligned with regulatory and data integrity requirements. Hybrid position across site activities.

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