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

Description

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.

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

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

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