Catalyx is seeking a Lab IT Systems Specialist to join our team and work 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:
We are seeking an experienced IT professional with strong technical troubleshooting and infrastructure knowledge who can operate effectively within a GMP-regulated environment. While validation and compliance experience are important, the successful candidate will be comfortable working with software applications, servers, operating systems and network-connected equipment.
The role focuses on the support, maintenance, troubleshooting, compliance and lifecycle management of laboratory computer systems and associated IT infrastructure. You will work closely with Laboratory Operations, Quality, Engineering, Automation and Global IT teams to ensure systems remain secure, compliant and operational.
This position would suit candidates coming from IT Infrastructure, Laboratory Systems Support, IT Compliance, Computer System Validation, Systems Administration or Pharmaceutical IT backgrounds.
Responsibilities:
Support the day-to-day operation, maintenance and troubleshooting of laboratory computer systems and associated software applications.
Provide technical support for laboratory instruments, instrument software and connected IT systems.
Support server, workstation and operating system activities associated with GMP laboratory environments.
Investigate and resolve system, software, connectivity and performance issues.
Support software installations, upgrades, patching and lifecycle management activities.
Work with vendors and internal stakeholders to troubleshoot application, infrastructure and instrument-related issues.
Support user access management, account administration and system security controls.
Participate in change control, deviation investigation, CAPA and periodic review activities.
Ensure systems remain compliant with GxP, Data Integrity and regulatory requirements.
Author, review and execute validation documentation including Validation Plans, Risk Assessments, IQ, OQ and PQ protocols where required.
Support audit and inspection readiness activities.
Assist with backup, recovery, disaster recovery and business continuity activities.
Support network-connected devices, interfaces and integrations between laboratory systems.
Contribute to cybersecurity and compliance initiatives affecting laboratory systems and infrastructure.
Maintain accurate technical and validation documentation throughout the system lifecycle.
Requirements:
Degree in Information Technology, Computer Science, Engineering or a related technical discipline.
Minimum 5 years' experience supporting IT systems within pharmaceutical, biotechnology, medical device or other regulated environments.
Strong hands-on IT troubleshooting experience.
Experience supporting Windows-based systems, servers and workstations.
Knowledge of operating systems, software deployment and system administration activities.
Experience supporting network-connected systems and troubleshooting connectivity issues.
Familiarity with networking fundamentals including TCP/IP, DNS, Active Directory and firewall concepts.
Experience with virtualised environments such as VMware.
Understanding of Computer System Validation (CSV) and GAMP 5 principles.
Experience supporting regulated systems throughout their lifecycle.
Knowledge of FDA 21 CFR Part 11, Annex 11, Data Integrity and GxP requirements.
Experience working with change controls, deviations, CAPAs and periodic reviews.
Strong communication and stakeholder management skills.
Ability to work independently while collaborating across multidisciplinary teams.
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.
