Lab CSV Engineer

Cognizant is a world leader in delivering digital transformation solutions to Life Sciences. Through our knowledge and expertise in Automation, MES & Digital, we deliver stable manufacturing systems that are optimized to improve operational efficiencies, whilst maintaining compliance.

Our specialist engineering teams have the aptitude to deliver and support Pharma 4.0 architectures and solutions covering all IT, OT and IoT applications, infrastructures and services.

Operating across 5 continents and with over 300.000 skilled employees, Cognizant partners with the leading Life Sciences companies globally to provide performance improvements, reduced costs and improve time to market. We are your single end to end partner for consultancy, design implementation, optimization and support for all applications in the Pharmaceutical and Biotechnology Manufacturing stack.

We're looking for dedicated, innovative and driven talent to join our expanding team.

Job summary

The Senior Validation Consultant is a hands-on, strategy-led technical role responsible for the computer system validation (CSV) of larger laboratory systems - including LIMS, the Lab Execution System (LES) built on LabVantage, and other laboratory systems - within the Quality workstream. The primary focus of this role is the validation strategy for systems incorporating artificial intelligence / machine-learning (AI/ML) components, ensuring these are validated for intended use in line with emerging regulatory expectations, including the draft EU GMP Annex 22 (Artificial Intelligence), Annex 11, GAMP 5 (Second Edition) and the ISPE GAMP Guide: Artificial Intelligence.

Alongside this AI focus, the consultant defines and owns the validation strategies and plans that govern how these larger systems are validated and maintained in a validated state. The consultant brings direct LIMS / LabVantage experience and sets the validation direction for AI-enabled applications while raising the bar of the broader validation framework.

Key Responsibilities:

• Validation of Larger Laboratory Systems (LIMS and other lab systems) - Lead the computer system validation of larger laboratory systems - LIMS, LES/LabVantage, and other laboratory systems - across their lifecycle.
• Provide senior CSV oversight for configuration of laboratory platforms to support QC workflows: sample login, testing assignments, instrument integration, specifications management, and results entry.
• Ensure analytical methods, test plans, and specifications configured within these systems are validated and traceable to approved laboratory SOPs and pharmacopeial methods.
• Ensure user roles, security permissions, electronic signatures, and audit trail settings are validated in compliance with 21 CFR Part 11 and EU Annex 11.
• Oversee validation of interfaces between laboratory systems and SAP (QM), MES, instruments, and EDMS.

Validation Strategy & Planning (CSV) - This role centres on defining the validation strategies and plans that govern how larger laboratory systems are validated. The consultant will:

• Define, author and own the overarching validation strategy and Validation Plans across LIMS, LES, MALDI-TOF, APQR and other laboratory systems.
• Set the risk-based validation approach in line with the GAMP 5 (2nd Ed.) framework, ICH Q9(R1) quality risk management, 21 CFR Part 11, EU Annex 11, and data integrity / ALCOA+ principles.
• Establish the structure and standards for the core validation deliverables - User Requirements Specification (URS), Functional Requirements Specification (FRS), Design Specification, Risk Assessment, Traceability Matrix, IQ/OQ/PQ approach, and Validation Summary Reports (VSR).
• Define validation scope, acceptance strategy, deliverable set, and the leverage of supplier documentation for each system based on risk and criticality.
• Define the strategy for periodic review, change-driven re-validation, and ongoing validated-state maintenance post go-live.
• Define the approach to deviation handling, remediation, and evidence standards so validation packages are consistent, defensible and inspection-ready.

Key competencies:

• Deep technical expertise in LIMS - comfortable in the system configuration layer, not just the user interface.
• Strong validation-strategy capability: able to define validation approaches and plans for large, complex laboratory systems.
• Validation mindset: meticulous, evidence-based documentation and zero tolerance for gaps in the validation package.
• Strong scientific and risk-based acumen - understands the “why” behind analytical methods, laboratory workflows and AI model behaviour, not just the mechanics.
• Ability to think strategically about emerging regulation (Annex 22) while executing hands-on validation work.
• Clear, structured technical writing for validation strategies, plans, SOPs and specifications.
• Collaborative, multidisciplinary approach - works effectively across QC lab teams, IT/data science, quality assurance, and vendors.
• Self-directed and proactive; manages own workload and flags risks and roadblocks early rather than letting them escalate.