About the job
Catalyx is excited to invite a skilled Lab Systems Engineer to become a vital part of our team at our customer site in Leiden.
About Us:
Catalyx is a pioneering machine vision and automation company dedicated to integrating advanced technology with human expertise, enabling global manufacturers and logistics firms to achieve unparalleled levels of quality and productivity. With over three decades of experience, our team has relentlessly worked to optimize operational processes across highly regulated sectors by developing innovative technology solutions and offering expert support. Operating from 9 international offices and boasting a workforce of over 550 dedicated professionals, we have successfully completed more than 3,000 projects and continue to push the boundaries of what's possible. For further details, please visit www.catalyx.ai.
The Opportunity:
We are in search of a Lab Systems Engineer with substantial experience, specifically in the pharmaceutical sector. This pivotal role involves ensuring that all IT systems and software meet stringent regulatory standards, operational needs, and industry best practices. The ideal candidate will possess a solid foundation in IT infrastructure, computer system validation (CSV), or regulatory compliance, particularly within highly regulated environments.
Key Responsibilities:
Implement Windows 11 upgrades on essential laboratory and manufacturing PCs.
Conduct system assessments to evaluate compatibility and readiness for upgrades.
Assist in validation efforts within GLP/GMP-regulated settings.
Design and execute test protocols, providing IQ/OQ support as necessary.
Collaborate with Lab IT, QA, Automation, and various site stakeholders.
Minimize disruption to operations during the upgrade process.
Support rollback and remediation plans when required.
Ensure compliance with cybersecurity and data integrity standards.
Engage in change control and deviation management processes.
Qualifications:
5+ years of experience in IT infrastructure or endpoint engineering.
Proven track record in supporting systems within GLP, GMP, or GxP regulated environments.
Experience with Windows OS migrations, particularly from Windows 10 to Windows 11.
Familiarity with validated systems and computer system validation (CSV) practices.
Knowledge of 21 CFR Part 11, data integrity, and audit trail regulations.
Experience in supporting laboratory instrumentation PCs, with a preference for analytical systems.
Strong documentation skills in regulated settings.
Experience with Change Control systems.

