Lab Systems Validation Specialist
Cognizant · Dublin
Job description
About the role
We are looking for a Lab Systems Validation Specialist to ensure our GxP‑regulated laboratory computer systems remain validated, compliant and inspection‑ready. The role combines IT administration, documentation and close collaboration with quality and validation teams.
Key responsibilities
- Generate SDLC, SOP and work instruction documents and maintain all technical and compliance artefacts such as system diagrams, configuration records and validation deliverables.
- Provide hands‑on IT administration and technical support for laboratory applications including LabX (Mettler Toledo), Empower (Waters), Cytiva ÄKTA systems and Wave Bioreactors.
- Administer Windows client and server environments – OS configuration, patching, hardening, service‑account management, user access and performance monitoring.
- Configure, document and maintain laboratory system architectures (servers, workstations, interfaces, network dependencies and integrations) with full traceability and change‑control.
- Support installation, upgrade and lifecycle management of instruments and associated software, ensuring GxP compliance, data‑integrity (ALCOA+) and validation requirements.
- Perform application administration tasks such as user/role configuration, access reviews, backup‑restore verification, health checks and troubleshooting.
- Coordinate vendor support, manage change‑control assessments and assist in deviation/incident investigations.
- Collaborate with QA, Validation and external vendors to prepare for audits and regulatory inspections.
Required profile
- Hands‑on experience supporting GxP laboratory computerized systems.
- Proven background in Windows client/server administration and system performance monitoring.
- Familiarity with validation documentation (URS, RA, IQ/OQ/PQ) and change‑control processes.
- Ability to produce and maintain SOPs, work instructions and audit evidence.
- Strong collaboration skills with QA, Validation and external vendors.
Required skills
- LabX (Mettler Toledo)
- Empower (Waters)
- Cytiva ÄKTA systems
- Wave Bioreactors
- Windows Server and client administration
- SDLC documentation
- GxP compliance and ALCOA+ data integrity
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Published 1 day ago
Expires 1 month from now
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Cognizant
Dublin
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