Computer System Validation Lead - Data Lake

PHARMACEUTICAL EXPERIENCE MANDATORY

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:

o        Data Lake Validation Plan

o        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:

o        GxP data source onboarding

o        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:

o        GAMP 5 Second Edition

o        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:

o        GAMP 5 Second Edition

o        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