Role Overview

The Computer System Validation (CSV) Consultant ensures GxP-relevant computer systems are validated, compliant, and fit for intended use across laboratory, manufacturing, enterprise, and cloud environments. The role plans and executes end-to-end CSV lifecycle deliverables in alignment with FDA, EMA/MHRA expectations, GAMP 5, and company SOPs. It partners with QA, IT, Manufacturing, R&D;, and business stakeholders to drive risk-based validation, robust documentation, and timely delivery. The consultant supports audits and inspections, leads data integrity assessments and remediation, and trains teams on CSV processes and standards. They also advise on evolving areas such as AI/ML-enabled systems, PV workflows, and continuous improvement of templates and procedures.

Required Qualifications
- Bachelors or Master’s in Computer Science, Life Sciences, Engineering, Pharmacy, or related field
- 3–8+ years of CSV experience within GxP-regulated industries (pharma, biotech, medical devices)
- Strong knowledge of GAMP 5, FDA 21 CFR Part 11, EU Annex 11,



and Data Integrity (ALCOA+) principles
- Hands-on validation of Laboratory systems (LIMS, CDS, ELN) and Manufacturing systems (MES, SCADA, PLCs)
- Experience validating ERP (SAP) and Cloud/SaaS systems (e.g., AWS, Azure, Veeva)
- Proficiency authoring CSV deliverables: Validation Plans, Risk Assessments, URS/FS/DS, IQ/OQ/PQ, Traceability Matrix, Validation Summary Report
- Demonstrated risk-based validation approach and prioritization of testing based on impact/criticality
- Experience supporting regulatory inspections and internal audits; solid documentation and communication skills
- Understanding of validation for AI/ML-enabled systems (intended use, data quality, explainability, drift monitoring, human oversight, revalidation triggers)
- Understanding of Pharmacovigilance (PV) processes and validation lifecycle support
- Familiarity with Agile/SDLC methodologies and testing tools (Jira, qTest, ALM)
- Nice t

📌 Computer System Validation (Bengaluru)
🏢 Mobilution It Systems
📍 Bengaluru