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.
The Cognizant community:
We are a high caliber team who appreciate and support one another. Our people uphold an energetic, collaborative and inclusive workplace where everyone can thrive.
- Cognizant is a global community with more than 300,000+ associates around the world.
- We don’t just dream of a better way – we make it happen.
- We take care of our people, clients, company, communities and climate by doing what’s right.
- We foster an innovative environment where you can build the career path that’s right for you.
About us:
Cognizant (Nasdaq: CTSH) is an AI Builder and technology services provider, building the bridge between AI investment and enterprise value by building full-stack AI solutions for our clients. Our deep industry, process and engineering expertise enables us to build an organization’s unique context into technology systems that amplify human potential, realize tangible returns and keep global enterprises ahead in a fast-changing world. See how at www.cognizant.com or @cognizant.
Cognizant is an equal opportunity employer. Your application and candidacy will not be considered based on race, color, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status or any other characteristic protected by federal, state or local laws.
Disclaimer:
Compensation information is accurate as of the date of this posting. Cognizant reserves the right to modify this information at any time, subject to applicable law.
Applicants may be required to attend interviews in person or by video conference. In addition, candidates may be required to present their current state or government issued ID during each interview.