Computer Systems Validation (CSV) Engineer

Catalyx is seeking a CSV Engineer with a strong focus on Lab IT Systems to join our existing team on our customer site in Cork

Who We Are:

Catalyx is a machine vision and automation company that integrates technology and people to help global manufacturers and logistics companies achieve next-generation levels of quality and throughput. For over thirty years, the minds behind Catalyx have been at work maximizing operational processes across highly regulated industries by inventing new technology applications and supporting companies with technical experts. With 9 global offices, over 550 team members, and 3,000 projects under our belt (and counting), we have the capabilities and reach to solve unique process problems at scale – and the vision to keep doing what’s never been done before. For more information visit www.catalyx.ai.

The Role:

Catalyx is looking for a Computer Systems Validation (CSV) Engineer with a strong focus on Lab IT Systems to support the validation of laboratory-based software, instruments, and integrated IT environments within a regulated setting. This role sits at the intersection of IT infrastructure and laboratory systems, with a focus on ensuring lab applications, instruments, and their underlying systems are fully validated and compliant.

You will work closely with IT, QA, Lab Operations, and Automation teams to ensure that all laboratory systems are implemented, validated, and maintained in line with regulatory requirements and internal standards. This is a hands-on role requiring strong technical understanding of both IT systems and lab-based applications.

Responsibilities:

• Lead and execute Computer Systems Validation activities for Lab IT Systems, including laboratory software, instruments, and integrated platforms.

• Develop, review, and approve validation documentation including IQ, OQ, and PQ with clear alignment to lab systems and supporting IT infrastructure.

• Validate laboratory systems such as LIMS, CDS, ELN, and other GxP-relevant applications, ensuring compliance with regulatory requirements.

• Support system installation, configuration, and qualification activities across lab environments, including instrument software and connected systems.

• Perform risk assessments aligned to lab system architecture, data integrity, and system interfaces.

• Work closely with IT teams on system builds, upgrades, patching, and deployments impacting lab systems to ensure validated state is maintained.

• Troubleshoot validation and system issues related to lab IT environments, including instrument connectivity, software configurations, network issues, and data flows.

• Support integration and validation of interconnected lab systems, including interfaces between instruments, applications, and enterprise systems.

• Ensure compliance with FDA 21 CFR Part 11, EU Annex 11, and GAMP 5, with a strong focus on data integrity and electronic records within lab systems.

• Maintain validation lifecycle activities including periodic reviews, revalidation, and change control for lab systems.

• Act as SME during audits and inspections, specifically in relation to lab systems validation and data integrity.

• Collaborate with QA, Lab Operations, IT, and Engineering teams to ensure systems are validated in line with project timelines.

• Support and oversee change control activities for lab IT systems, ensuring all updates and changes are assessed and remain compliant.

• Develop and maintain validation documentation including validation plans, traceability matrices, and summary reports.

Requirements:

• Bachelor’s degree in Computer Science, Information Technology, Engineering, or a related technical discipline.

• 3–5+ years of experience in Computer Systems Validation with a focus on IT Systems.

• Experience working in regulated environments such as pharmaceutical, biotech, or medical devices.

• Hands-on experience with laboratory systems such as LIMS, CDS, ELN, or similar platforms would be an advantage.

• Experience with system configuration, upgrades, patching, and troubleshooting.

• Experience with scripting, automation, or system administration is an advantage.

• Strong communication and stakeholder management skills.

Why Join Catalyx?

At Catalyx we understand that our people are our greatest asset. For this reason and many others, we take care of them. The team in Catalyx benefits from a Total Rewards package. This includes great personal benefits and professional growth opportunities.

Catalyx is an Equal Opportunity Employer. We are committed to creating a diverse and inclusive workplace where all individuals are valued, respected, and supported. We do not discriminate on the basis of race, colour, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, veteran status, genetic information, or any other characteristic protected by applicable law. We encourage applications from all qualified candidates, regardless of background, and strive to create a welcoming environment for everyone.

At Catalyx, we are committed to attracting the best global talent. We proudly support our international employees by offering assistance with Critical Skills Visa applications for eligible candidates.