6424 - Lead Validation Engineer (Data Lake) / CSV Engineer

About the role

Verista's 500 experts team up with the world's most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world's most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities. Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day. Company Culture Guidelines & Values: We empower and support our colleagues We commit to client success at every turn We have the courage to do the right thing We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged. We constantly acquire new skills and learn from our experiences to enhance our collective expertise Validation Engineer (Data Lake) Responsibilities: Qualification Strategy & Validation Leadership Lead qualification activities for an enterprise cloud-based Data Lake platform using modern, risk-based CSA methodologies. Assess the current architecture, existing validation deliverables, and identify opportunities to simplify and modernize 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. Validation Planning & Documentation 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 minimize unnecessary documentation. Testing & Verification 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. Governance & Lifecycle Management 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 Develop Data Lake Administration SOPs and associated work instructions. Support implementation and governance of Power BI solutions used for GxP business processes. Compliance & Risk Management 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.

Requirements

• Bachelor's degree in Computer Science, Engineering, Information Systems, Life Sciences, or 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.
• 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
• *Verista is an equal opportunity employer.
• Nationa

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