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

Verista, Inc.•Conshohocken, PA

3d•$87,780 - $136,225

About The Position

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

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.

Nice To Haves

Experience with one or more of the following technologies: Microsoft Azure, Azure Data Lake Storage, Azure Data Factory, Databricks, Microsoft Fabric, Power BI
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

Responsibilities

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.
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.
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 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.
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.