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
Equal Opportunity Statement
Cognizant is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
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