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

3 weeks, 5 days ago
United States
Full-time
Lead
Cloud Engineer
DevOps and Infrastructure
Azure Databricks Power BI
Apply Now
Verista

Verista

Verista provides transformative compliance, automation, validation, and packaging solutions for the life sciences, pharmaceutical, and manufacturing industries, ensuring consistent, safe, and high-quality results every time.

Pharmaceuticals
251-1K
Founded 2020
View All Jobs 4

Description

  • Lead qualification activities for an enterprise cloud-based Data Lake platform using risk-based CSA methodologies.
  • Assess current architecture and validation deliverables to simplify and modernize qualification while maintaining compliance.
  • Develop and implement a scalable qualification model for onboarding future GxP systems, data sources, interfaces, and pipelines.
  • Establish sustainable validation and governance procedures for both GxP and non-GxP use cases.
  • Author and maintain validation plans, requirements specifications, technical specifications, as-built configuration documentation, IQ/OQ protocols, and validation/test summary reports.
  • Develop documentation approaches that leverage platform automation and minimize unnecessary documentation.
  • Define streamlined testing strategies focused on critical infrastructure and business processes.
  • Facilitate and coordinate testing activities executed by Data and Infrastructure teams.
  • Implement targeted verification approaches aligned with CSA principles.
  • Develop governance procedures, change control processes, and SOPs for the enterprise data platform.
  • Support implementation and governance of Power BI solutions used for GxP business processes.
  • Ensure validation deliverables support lifecycle management, change control, and regulatory compliance.

Requirements

  • 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 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, and change management/SDLC processes.
  • Experience authoring and executing validation documentation.
  • Strong stakeholder management and communication skills.
  • Experience with Microsoft Azure, Azure Data Lake Storage, Azure Data Factory, Databricks, Microsoft Fabric, or Power BI is preferred.
  • Additional preferred experience in enterprise data lakes, data governance, data engineering, analytics platforms, GxP data pipelines and interfaces, infrastructure qualification, SaaS/PaaS/cloud validation, or pharmaceutical manufacturing, quality, or R&D systems.

Benefits

  • National US salary range of $87,780 to $136,225 USD.
  • Competitive pay plus performance-based incentive programs.
  • Company-paid life, short-term disability, and long-term disability insurance.
  • Medical, dental, and vision insurance.
  • Health Savings Account (HSA), FSA, DCARE, and commuter benefits.
  • 401(k) retirement plan with employer matching.
  • Paid time off with rollover option, paid holidays, and as-needed sick time.
  • Tuition reimbursement, paid parental leave, bereavement leave, employee recognition, referral program, and team social activities.

Interested in this position?

Apply directly on the company website

Apply Now

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