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Computer Systems Validation Engineer - Lab IT Systems

On-site Full-time

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Experience Level

Experience

Qualifications

Qualifications:Bachelor's degree in Computer Science, Engineering, or a related field. Proven experience in Computer Systems Validation within a regulated laboratory environment. Strong understanding of laboratory IT systems, including LIMS, CDS, and ELN. Familiarity with regulatory requirements (FDA, EMA, etc.) and industry standards. Excellent problem-solving skills and attention to detail. Ability to work collaboratively with cross-functional teams.

About the job

Location: Cork
Company: Catalyx

Catalyx specializes in machine vision and automation for manufacturers and logistics firms across the globe. With a 30-year track record, the team works with highly regulated industries, applying technology and expertise to improve operations. Catalyx operates in nine countries, employs over 550 professionals, and has delivered more than 3,000 projects. More details can be found at www.catalyx.ai.

Role overview

The Computer Systems Validation Engineer - Lab IT Systems plays a key role in validating laboratory software and instrumentation within a regulated environment. The position bridges IT infrastructure and lab operations, ensuring that applications, instruments, and supporting systems comply with validation and regulatory standards. Collaboration with IT, Quality Assurance, Laboratory Operations, and Automation teams is central to this role. Strong technical understanding of both IT systems and laboratory applications is essential.

Main responsibilities

  • Lead and execute Computer Systems Validation (CSV) activities for Lab IT Systems, including laboratory software, instruments, and integrated platforms.
  • Prepare, review, and approve validation documentation such as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), ensuring these align with laboratory systems and IT infrastructure.
  • Validate laboratory systems such as LIMS, CDS, ELN, and other GxP-compliant applications to meet regulatory requirements.
  • Support installation, configuration, and qualification of laboratory environments, covering both instrument software and connected systems.
  • Conduct risk assessments related to lab system architecture, data integrity, and system interfaces.
  • Collaborate with IT teams on system builds, upgrades, patches, and deployments that impact lab systems to maintain validated status.
  • Troubleshoot validation and system issues involving laboratory applications and IT systems.

About Catalyx

Catalyx is a leader in machine vision and automation, dedicated to helping manufacturers and logistics companies achieve next-gen quality and efficiency. With over thirty years of experience, our innovative solutions and skilled team consistently deliver exceptional results in highly regulated environments.

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