Lead Validation Engineer (Data Lake) / CSV Engineer

Key Responsibilities

• Lead qualification activities for an enterprise cloud-based Data Lake using risk-based CSA methodologies.
• Assess existing platform architecture and validation documentation to improve and modernize qualification processes.
• Develop scalable validation strategies for onboarding GxP systems, data sources, interfaces, and data pipelines.
• Establish validation and governance procedures supporting both GxP and non-GxP environments.
• Author and maintain: Validation Plans, Requirements Specifications, Technical Specifications & As-Built Documentation, Installation Qualification (IQ) Protocols, Operational Qualification (OQ) Protocols, Validation Summary Reports (VSR), Test Summary Reports (TSR).
• Develop efficient documentation practices that leverage automation while maintaining compliance.
• Define risk-based testing strategies aligned with CSA principles.
• Care for ongoing lifecycle management, periodic reviews, and change control activities.
• Develop Data Lake Administration SOPs and support validation of Power BI solutions used for GxP business processes.
• Establish governance procedures for enterprise Data Lake platforms.
• Support qualification of GxP data sources, interfaces, data pipelines, and platform enhancements.
• Ensure compliance with GAMP 5 Second Edition, FDA CSA Guidance, 21 CFR Part 11, EU Annex 11, Data Integrity (ALCOA+), and Good Documentation Practices (GDP).
• Utilize supplier assessments, cloud platform controls, and risk-based verification methodologies.

Required Qualifications

• Bachelor's degree in Computer Science, Engineering, Information Systems, Life Sciences, or a related discipline.
• 8+ years of Computer System Validation (CSV), CSA, or IT Compliance experience in pharmaceutical, biotechnology, or other regulated industries.
• Hands-on experience validating cloud-based platforms and infrastructure.
• Strong understanding of GAMP 5 Second Edition, FDA CSA Guidance, 21 CFR Part 11, EU Annex 11, Data Integrity, SDLC, and Change Management.
• Experience authoring and executing validation documentation including Validation Plans, IQ/OQ Protocols, VSRs, and TSRs.
• Excellent communication, documentation, and stakeholder management skills.

Preferred Qualifications

• Experience with: Microsoft Azure, Azure Data Lake Storage (ADLS), Azure Data Factory (ADF), Databricks, Microsoft Fabric, Power BI.