Lab Systems Engineer

CatalyxLeiden

On-site Full-time

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Experience Level

Experience

Qualifications

To be successful in this role, candidates should have:A minimum of 5 years of experience in IT infrastructure or endpoint engineering. Proven experience supporting systems in 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). Understanding of 21 CFR Part 11, data integrity, and audit trail requirements. Experience supporting laboratory instrumentation PCs, preferably analytical systems. Strong documentation skills in regulated environments. Experience working with Change Control systems.

About the job

Catalyx is actively seeking a skilled Lab Systems Engineer to become a key member of our team at a customer site in Leiden.

About Us:

Catalyx is a leader in machine vision and automation technology, dedicated to empowering global manufacturers and logistics firms to reach unprecedented levels of quality and productivity. With over three decades of experience, our innovative team has been enhancing operational processes across highly regulated sectors by developing cutting-edge technology solutions and providing expert support. With 9 offices worldwide and a diverse team of over 550 professionals, we've successfully completed more than 3,000 projects. We pride ourselves on our ability to tackle unique process challenges at scale and are committed to pioneering what has yet to be accomplished. To learn more about us, visit www.catalyx.ai.

Position Overview:

We are looking for an experienced Lab Systems Engineer to join our team, focusing on the pharmaceutical industry. This pivotal role involves ensuring that all IT systems and software adhere to regulatory requirements, operational needs, and industry best practices. The ideal candidate will possess a robust background in IT infrastructure, computer system validation (CSV), or regulatory compliance, with prior experience in a pharmaceutical or similarly regulated environment.

Key Responsibilities:

Execute Windows 11 upgrades on essential laboratory and manufacturing PCs.
Conduct system assessments to ascertain compatibility and readiness for upgrades.
Support validation activities within GLP/GMP-regulated environments.
Develop and implement testing protocols (IQ/OQ support as necessary).
Collaborate with Lab IT, QA, Automation, and site stakeholders.
Minimize operational disruptions during the upgrade process.
Assist with rollback and remediation strategies as needed.
Ensure the maintenance of cybersecurity and data integrity standards.
Engage in change control processes and manage deviations appropriately.

Qualifications:

A minimum of 5 years of experience in IT infrastructure or endpoint engineering.
Proven experience supporting systems in GLP, GMP, or GxP regulated settings.
Experience with Windows OS migrations, particularly from Windows 10 to Windows 11.
Familiarity with validated systems and computer system validation (CSV).
Knowledge of 21 CFR Part 11, data integrity, and audit trail requirements.
Experience in supporting laboratory instrumentation PCs, with a preference for analytical systems.
Strong documentation skills in regulated environments.
Experience with Change Control systems.

About Catalyx

Catalyx is a pioneering machine vision and automation technology company focused on enhancing the operational efficiency of global manufacturers and logistics companies. With over 30 years of experience and a commitment to innovation, we strive to help our clients achieve top-tier quality and productivity. Our team, consisting of more than 550 professionals across 9 offices worldwide, has successfully executed over 3,000 projects, cementing our reputation as a leader in solving complex process challenges.

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