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

United States·Conshohockenlead

QA & TestingValidation Engineer

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Quick Summary

Overview

Description Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs.

Technical Tools

QA & TestingValidation Engineer

Description

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

Responsibilities

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Requirements

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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.

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

For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.

*Verista is an equal opportunity employer.

National (US) Range

$87,780—$136,225 USD

Benefits

Why Choose Verista?

High growth potential and fast-paced organization with a people-focused culture
Competitive pay plus performance-based incentive programs
Company-paid Life, Short-Term, and Long-Term Disability Insurance.
Medical, Dental & Vision insurances
FSA, DCARE, Commuter Benefits
Supplemental Life, Hospital, Critical Illness and Legal Insurance
Health Savings Account
401(k) Retirement Plan (Employer Matching benefit)
Paid Time Off (Rollover Option) and Holidays
As Needed Sick Time
Tuition Reimbursement
Team Social Activities (We have fun!)
Employee Recognition
Employee Referral Program
Paid Parental Leave and Bereavement

Verista collects and processes personal data in accordance with applicable data protection laws. If you are a California Job Applicant, see the privacy notice for further details.

For more information about our company, please visit us at Verista.com

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.