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 to have: Cloud/SaaS validation experience with AWS, Azure, Veeva; prior regulatory inspection participation; knowledge of 21 CFR 820, ISO 13485, ISO 14971
- Additionally, experience supporting eLearning platforms and understanding PM patterns and challenges for such platforms

Responsibilities

- Execute CSV activities for GxP applications, lab systems, manufacturing systems, ERP/SAP, and cloud/SaaS platforms
- Develop and review Validation Plans, Risk Assessments, URS, FS, DS, IQ/OQ/PQ protocols and reports, Traceability Matrices, and Validation Summary Reports
- Ensure compliance with FDA 21 CFR Part 11, EU Annex 11, GAMP 5, ICH Q7/Q10, and company SOPs
- Perform risk-based assessments to scope and prioritize validation testing, including impact and criticality assessments
- Collaborate with QA, IT, Manufacturing, R&D;, and business stakeholders to plan, execute, and deliver validation on time
- Provide audit/inspection support, address findings, and maintain audit-ready documentation
- Conduct data integrity assessments and lead remediation activities aligned to ALCOA+
- Train project teams on CSV processes, documentation standards, data integrity, and compliance requirements
- Contribute to continuous improvement of CSV procedures, templates, and best practices
- Support validation considerations for AI/ML-enabled systems, PV workflows, and cloud/SaaS shared responsibility models

📌 Computer System Validation (CSV) Consultant (Hyderabad)
🏢 Mobilution It Systems
📍 Hyderabad