Lead Validation Engineer, Data Analytics/AI

🕒 May 27

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

💵 $87.8k - $118.1k / year

⏰ Full Time

🟠 Senior

📉 Data Analyst

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Verista, Inc.

WebsiteLinkedInAll Job Openings

501 - 1000 employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Verista, Inc. is a service provider specializing in solutions for the life sciences, biotech, pharmaceuticals, and medical devices sectors. They offer expertise in areas such as commissioning, qualification, and validation, vision and systems integration, technology solutions, data analytics and strategy, cybersecurity, digital transformation, regulatory compliance, and infrastructure management. Verista excels in providing managed services, program and project management, and digital strategy to ensure quality and compliance throughout the product lifecycle. Their focus on personalized engagement and effective communication makes them a favored partner among top life sciences companies worldwide.

📋 Description

• 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

• 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