Verista, Inc. logo
Verista, Inc.

Transformative business, compliance, and technology solutions for the life sciences industry

Lead Validation Engineer, Data Analytics/AI

Data AnalystData AnalystFull TimeRemoteSeniorTeam 501-1,000H1B No SponsorCompany SiteLinkedIn

Location

Pennsylvania

Posted

3 days ago

Salary

$87.8K - $118.1K / year

Seniority

Senior

Bachelor Degree5 yrs expEnglishAWSAzureCloudSDLCTableau

Job Description

Lead Validation Engineer, Data Analytics/AI

Verista, Inc.

• 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

Job Requirements

  • 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

  • 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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