Catalyx is seeking an experienced Systems Engineer to support / upgrade laboratory systems operating within regulated GLP and GMP environments.
Key Responsibilities
· Execute Windows 11 upgrades on business-critical laboratory and manufacturing PCs
· Perform system assessments to determine compatibility and upgrade readiness
· Support validation activities in GLP/GMP-regulated environments
· Develop and execute test protocols (IQ/OQ support as required)
· Coordinate with Lab IT, QA, Automation, and site stakeholders
· Minimize operational disruption during upgrade execution
· Support rollback and remediation plans if required
· Ensure cybersecurity and data integrity standards are maintained
· Participate in change control processes and deviation management
Requirements
· 5+ years of IT infrastructure or endpoint engineering experience
· Direct experience supporting systems in GLP, GMP, or GxP regulated environments
· Experience with Windows OS migrations (Windows 10 to Windows 11 preferred)
· 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 (analytical systems preferred)
· Strong documentation skills in regulated environments
· Experience working with Change Control systems
Preferred Experience
· Experience supporting pharmaceutical or biotechnology companies
· Exposure to validated lab applications (e.g., chromatography systems, LIMS, Empower, etc.)
· Knowledge of manufacturing systems (MES, SCADA, DCS interfaces)
· Familiarity with SCCM, Intune, or enterprise deployment tools
· Experience in regulated packaging or manufacturing environments
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