Senior CSV Engineer - AI-Driven LIMS Validation

Cognizant Technology Solutions Corporation; Dublin; On-site; EUR 90,000 - 130,000; Full time

Job summary

The Senior Validation Consultant at Cognizant Technology Solutions Corporation is a hands-on, strategy-led role focused on CSV of large laboratory systems (LIMS, LES/LabVantage) within the Quality workstream. It emphasizes AI/ML components and alignment with EU GMP Annex 22, Annex 11 and GAMP 5.

You will define validation strategies, own validation plans, and supervise end-to-end validation across systems, ensuring regulatory compliance and inspection readiness.

Qualifications

• Extensive LIMS and laboratory system validation experience.
• Ability to define and own validation strategies and plans.
• Strong focus on data integrity, risk management and regulatory alignment.

Responsibilities

• Lead CSV for large lab systems (LIMS, LES/LabVantage) across their lifecycle.
• Provide senior CSV oversight for configuration of QC workflows and instrument integration.
• Ensure validation of methods, SOPs, and electronic records with 21 CFR Part 11 and EU Annex 11.
• Oversee interfaces between lab systems and SAP (QM), MES, and EDMS.
• Develop validation deliverables: URS, FRS, risk assessment, IQ/OQ/PQ, VSR.

Skills

LIMS validation

Validation strategy

Documentation discipline

Analytical and risk-based thinking

Regulatory awareness (EU Annex 22/11,

Tools

LabVantage

SAP QM

MES

EDMS

Job description

The Senior Validation Consultant at Cognizant Technology Solutions Corporation is a hands-on, strategy-led role focused on CSV of large laboratory systems (LIMS, LES/LabVantage) within the Quality workstream. It emphasizes AI/ML components and alignment with EU GMP Annex 22, Annex 11 and GAMP 5.

You will define validation strategies, own validation plans, and supervise end-to-end validation across systems, ensuring regulatory compliance and inspection readiness.