About the job
Catalyx is on the lookout for a dedicated Computer Systems Validation (CSV) Engineer with expertise in Lab IT Systems to enhance our team at a client site in Cork.
About Catalyx:
With a robust legacy of over thirty years, Catalyx is a pioneering machine vision and automation company dedicated to empowering global manufacturers and logistics firms to reach unprecedented levels of quality and efficiency. Our team of over 550 experts operates from nine global offices, tackling more than 3,000 projects and continuously innovating technology applications while providing top-notch technical support. Explore our journey at www.catalyx.ai.
The Opportunity:
As a Computer Systems Validation (CSV) Engineer, you will play a pivotal role in the validation of laboratory software, instruments, and integrated IT environments within a regulated environment. This position intersects IT infrastructure and lab systems, focusing on ensuring compliance and full validation of lab applications and instruments.
Your collaborative efforts with IT, QA, Lab Operations, and Automation teams will be crucial in implementing, validating, and maintaining laboratory systems in accordance with regulatory standards and internal guidelines. This hands-on role demands a robust technical understanding of both IT systems and lab applications.
Key Responsibilities:
Lead and carry out Computer Systems Validation tasks for Lab IT Systems, including laboratory software, instruments, and integrated platforms.
Draft, review, and approve validation documentation such as IQ, OQ, and PQ, ensuring alignment with lab systems and IT infrastructure.
Validate laboratory systems like LIMS, CDS, ELN, and other GxP-relevant applications, ensuring compliance with applicable regulations.
Assist in system installation, configuration, and qualification across lab environments, including instrument software and connected systems.
Conduct risk assessments associated with lab system architecture, data integrity, and system interfaces.
Collaborate with IT teams on system builds, upgrades, patching, and deployments affecting lab systems to maintain validation status.
Troubleshoot validation and system issues to ensure operational continuity.

