Lab Systems Validation Specialist

Lab Systems Validation Specialist

The Lab System Validation resource will be responsible to,

• Generate SDLC (CS), SOP\WI (Administration) documents
• Own and maintain technical and compliance documentation, including system diagrams, configuration records, SOPs, validation deliverables, and audit evidence, ensuring systems meet regulatory and internal IT governance requirements.
• Provide hands on IT administration and technical support for GxP laboratory computerized systems, including client server and standalone applications such as LabX (Mettler Toledo), Empower (Waters), Cytiva ÄKTA systems, and Wave Bioreactors, ensuring systems remain validated, compliant, and inspection ready.
• Administer and support Windows client and server environments supporting laboratory systems, including OS configuration, patching, hardening, service accounts, user access management, and system performance monitoring in accordance with IT and Quality standards.
• Configure, document, and maintain laboratory system architectures (servers, workstations, interfaces, network dependencies, integrations), aligned with approved configuration specifications, ensuring full traceability, version control, and change management.
• Support the installation, upgrade, and lifecycle management of laboratory instruments and associated software, including application configuration, database connectivity, drivers, and vendor specific services, while ensuring compliance with GxP, data integrity (ALCOA+), and validation requirements.
• Perform application administration activities such as:
• User and role configuration
• Access and periodic review support
• Backup and restore verification
• System health checks and troubleshooting
• Coordination of vendor technical support and upgrades
• Collaborate closely with QA, Validation and external vendors to support:
• Change control and impact assessments
• Deviation and incident investigations
• Support Validation activities (URS, RA, IQ/OQ/PQ)
• Audit preparation and regulatory inspections
• Own and maintain technical and compliance documentation, including system diagrams, configuration records, SOPs, validation deliverables, and audit evidence, ensuring systems meet regulatory and internal IT governance requirements.