About the job
Catalyx is on the lookout for a talented Lab Systems Engineer to join our dynamic team at our client site in Puurs.
About Us:
Catalyx stands at the forefront of machine vision and automation, dedicated to integrating cutting-edge technology with human expertise. For over three decades, we have empowered global manufacturers and logistics companies to achieve unparalleled quality and efficiency. With nine offices worldwide and a team of over 550 professionals, we have successfully completed more than 3,000 projects, continually pushing the boundaries of innovation in highly regulated industries. To learn more, visit www.catalyx.ai.
The Position:
We are seeking a skilled Lab Systems Engineer with experience in the pharmaceutical industry. This pivotal role involves ensuring the alignment of IT systems and software with regulatory standards, operational needs, and industry best practices. The ideal candidate will possess a solid background in IT infrastructure, computer system validation (CSV), and regulatory compliance, particularly within a pharmaceutical or similarly regulated context.
Key Responsibilities:
Implement Windows 11 upgrades on essential laboratory and manufacturing PCs.
Conduct system evaluations to assess compatibility and readiness for upgrades.
Assist in validation processes within GLP/GMP-regulated environments.
Create and execute test protocols (including IQ/OQ support as necessary).
Collaborate with Lab IT, QA, Automation, and relevant site stakeholders.
Ensure minimal operational disruption during the upgrade process.
Support rollback and remediation strategies as needed.
Maintain cybersecurity and data integrity standards.
Engage in change control processes and deviation management.
Qualifications:
Minimum of 5 years of experience in IT infrastructure or endpoint engineering.
Proven experience in supporting systems within GLP, GMP, or GxP regulated settings.
Experience with Windows OS migrations (preferably from Windows 10 to Windows 11).
Familiarity with validated systems and computer system validation (CSV) processes.
Knowledge of 21 CFR Part 11, data integrity, and audit trail requirements.
