Lead Validation Engineer (Data Lake / CSV Engineer)

Responsibilities

• Lead qualification activities for an enterprise cloud-based Data Lake platform using modern, risk-based CSA methodologies.
• Assess the current architecture and existing validation deliverables, and identify opportunities to simplify and modernise qualification activities while maintaining compliance.
• Develop and implement a scalable qualification model supporting future onboarding of GxP systems, data sources, interfaces, and pipelines.
• Establish sustainable validation and governance procedures supporting both GxP and non-GxP use cases.
• Author and maintain: Data Lake Validation Plan, Requirements Specifications, Technical Specifications and As-Built Configuration Documentation, Infrastructure Qualification (IQ) Protocols, Operational Qualification (OQ) Protocols, Validation Summary Reports, Test Summary Reports.
• Develop sustainable documentation approaches that leverage platform automation and minimise unnecessary documentation.
• Define streamlined testing strategies focused on critical infrastructure and business processes.
• Facilitate and coordinate testing activities executed by the Data and Infrastructure teams.
• Implement targeted verification approaches aligned with CSA principles.
• Ensure validation deliverables support ongoing lifecycle management and change control.
• Develop Data Lake Administration SOPs and associated work instructions.
• Support implementation and governance of Power BI solutions used for GxP business processes.
• Develop and implement governance procedures for the enterprise data platform.
• Establish change control processes supporting: GxP data source onboarding, Data pipeline qualification, Interface assessments, Ongoing platform enhancements.
• Ensure alignment with: GAMP 5 Second Edition, Computer Software Assurance (CSA) guidance, 21 CFR Part 11, EU GMP Annex 11, Data Integrity requirements, Good Documentation Practices (GDP).
• Leverage supplier assessments, cloud platform controls, and risk-based verification methodologies.

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 within pharmaceutical, biotechnology, or regulated environments.
• Strong experience qualifying cloud-based platforms and infrastructure.
• Demonstrated experience implementing risk-based CSA methodologies.
• Deep understanding of: GAMP 5 Second Edition, FDA CSA Guidance, 21 CFR Part 11, EU Annex 11, Data Integrity principles, Change Management and SDLC processes.
• Experience authoring and executing validation documentation.
• Strong stakeholder management and communication skills.

Preferred Qualifications

• Experience with one or more of the following technologies: Microsoft Azure, Azure Data Lake Storage, Azure Data Factory, Databricks, Microsoft Fabric, Power BI.
• Additional preferred experience: Enterprise Data Lakes, Data Governance and Data Engineering, Analytics Platforms, GxP Data Pipelines and Interfaces, Infrastructure Qualification, SaaS, PaaS, and Cloud Validation, Pharmaceutical Manufacturing, Quality, or R&D systems.