Lead Validation Engineer, Data Analytics/AI

🕒 Maio 27

🔔 Pennsylvania – Remoto

🔔 Pennsylvania – Remote

💵 $87.780 - $118.062 / ano

⏰ Tempo Integral

🟠 Sênior

📉 Analista de Dados

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Verista, Inc.

SiteLinkedInTodas as Vagas

501 - 1000 funcionários

🧬 Biotecnologia

💊 Farmacêutico

⚕️ Seguro de Saúde

Biotechnology • Pharmaceuticals • Healthcare Insurance

A Verista, Inc. é uma provedora de serviços especializada em soluções para os setores de ciências biológicas, biotecnologia, farmacêutico e dispositivos médicos. Eles oferecem expertise em áreas como comissionamento, qualificação e validação, integração de visão e sistemas, soluções tecnológicas, análise e estratégia de dados, cibersegurança, transformação digital, conformidade regulatória e gestão de infraestrutura. A Verista se destaca na prestação de serviços gerenciados, gestão de programas e projetos, e estratégia digital para garantir qualidade e conformidade ao longo do ciclo de vida do produto. Seu foco em engajamento personalizado e comunicação eficaz faz deles um parceiro preferido entre as principais empresas de ciências biológicas em todo o mundo.

Descrição

• 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

🎯 Requisitos

• 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

🏖️ Benefícios

• 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