Lab IT Systems Specialist

Company Overview

Catalyx is a technology leader specializing in machine vision and automation, helping worldwide manufacturers and logistics firms boost quality and throughput through innovative solutions. With over 30 years of expertise, 9 global offices, and more than 550 employees, Catalyx has successfully executed over 3,000 projects, addressing complex operational challenges in highly regulated sectors.

Position Summary

We are hiring a Lab IT Systems Specialist to be based at our customer site in Cork, Ireland. The successful candidate will be a skilled IT professional with comprehensive troubleshooting and infrastructure expertise, adept at navigating GMP-regulated environments. This role demands proficiency with software applications, servers, operating systems, and networked lab equipment.

Key Responsibilities

• Manage daily operations, maintenance, and troubleshooting of lab computer systems and related software.
• Provide technical support for laboratory instruments, their software, and connected IT infrastructure.
• Administer server, workstation, and OS functions in compliance with GMP lab requirements.
• Diagnose and resolve system, software, connectivity, and performance issues promptly.
• Oversee software installation, updates, patching, and lifecycle management activities.
• Collaborate with vendors and internal teams to investigate and resolve issues related to applications, infrastructure, and instruments.
• Handle user account management, access controls, and system security measures.
• Participate actively in change control processes, deviation investigations, CAPA, and periodic system reviews.
• Ensure ongoing compliance with GxP, Data Integrity, and regulatory standards.
• Develop, review, and execute validation documentation including plans, risk assessments, and qualification protocols (IQ, OQ, PQ) as needed.
• Support audit readiness and inspection preparation activities.
• Assist with backup, recovery, disaster recovery, and business continuity planning.
• Maintain and support network-connected devices and integrations within laboratory systems.
• Contribute to cybersecurity and compliance initiatives impacting lab IT infrastructure.
• Keep accurate technical and validation documentation throughout the lifecycle of systems.

Qualifications and Skills

• Degree in Information Technology, Computer Science, Engineering, or equivalent technical field.
• At least 5 years of experience managing IT systems in pharmaceutical, biotech, medical device, or similarly regulated environments.
• Proven hands-on skills in IT troubleshooting with Windows-based systems, servers, and workstations.
• Knowledgeable in operating systems, software deployment methodologies, and system administration.
• Experience supporting networked systems with troubleshooting of connectivity problems.
• Understanding of networking fundamentals including TCP/IP, DNS, Active Directory, and firewall configurations.
• Experience working with virtualized environments such as VMware.
• Familiarity with Computer System Validation (CSV) and GAMP 5 guidelines.
• Experience supporting regulated IT systems across their full lifecycle.
• Knowledge of FDA 21 CFR Part 11, Annex 11, Data Integrity principles, and GxP compliance.
• Experience participating in change control, deviation investigations, CAPA processes, and periodic system reviews.
• Excellent communication and ability to manage multiple stakeholders.
• Capability to work independently while collaborating within multidisciplinary teams.

Why Work at Catalyx?

We value our people as our most crucial resource, offering a comprehensive Total Rewards package that supports personal benefits and professional development. Catalyx maintains an inclusive, diverse workplace that values respect and equal opportunity for all qualified candidates, without discrimination. We also assist international hires with Critical Skills Visa applications when applicable.