Lead Validation Engineer, Data Analytics/AI

Verista, Inc.

Lead Validation Engineer supporting GxP compliance activities across Data Analytics, AI, ML platforms for Verista. Collaborating with stakeholders to ensure compliance in regulated environments.

Posted 5/27/2026full-timeRemote • Pennsylvania • 🇺🇸 United StatesSenior💰 $87,780 - $118,062 per yearWebsite

Tech Stack

Tools & technologies

AWSAzureCloudSDLCTableau

About the role

Key responsibilities & impact

Provide CSA / CSV subject matter expertise across Data Analytics, AI, Machine Learning, and Digital platforms
Support system implementations, enhancements, integrations, upgrades, and data migrations from a compliance perspective
Develop and review validation deliverables including Validation Plans, Risk Assessments, Traceability Matrices, and Validation Summary Reports
Review and approve lifecycle documentation (URS, specifications, test plans, test summaries) in alignment with ALCOA+ and Good Documentation Practices
Assess AI/ML solutions and analytics platforms to determine appropriate risk-based assurance activities
Oversee validation readiness and ensure prerequisites are met prior to formal testing
Support change control, configuration management, and release activities
Partner with Quality, System Owners, Data Owners, and Business Process Owners to ensure ongoing compliance
Provide guidance on CSA-based, risk-driven validation approaches for analytics and AI-enabled solutions
Support supplier assessments, vendor documentation reviews, and leveraging of vendor testing where appropriate

Requirements

What you’ll need

5–8 years of hands-on experience supporting GxP systems, Data Analytics platforms, Artificial Intelligence solutions, or a combination of these domains
Hands-on experience supporting cloud-based, SaaS, COTS, or enterprise data platforms in regulated environments
Strong understanding of CSA principles, CSV, and SDLC processes
Experience authoring and/or reviewing validation documentation
Working knowledge of GxP regulations (e.g., FDA, EMA, ICH), data integrity requirements, and ALCOA+ principles
Familiarity with AI, Machine Learning, advanced analytics, or business intelligence platforms
Ability to work independently in a fast-paced, matrixed environment
Strong communication skills and comfort interacting with Quality, IT, Data, and business stakeholders
Experience Machine Learning, Business Intelligence, Data Lake, Data Warehouse, or Digital Transformation platforms preferred
Experience with technologies such as Power BI, Tableau, Snowflake, Databricks, Azure, AWS, Google Cloud, or similar platforms preferred
Familiarity with electronic quality systems, change management tools, or application lifecycle management platforms preferred
Experience supporting AI governance, model lifecycle management, or emerging AI compliance frameworks preferred

Benefits

Comp & perks

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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Data AnalyticsArtificial IntelligenceMachine LearningValidation PlansRisk AssessmentsTraceability MatricesValidation Summary ReportsGxP systemsCSVSDLC processes

Soft Skills

strong communication skillsability to work independentlycomfort interacting with stakeholdersguidance on risk-driven validation approaches