Lead Validation Engineer, Data Analytics/AI

🕒 il y a 10 jours

🔔 Pennsylvania – Distant

🔔 Pennsylvania – Remote

💵 $87 780 - $118 062 / an

⏰ Temps Plein

🟠 Senior

📉 Analyste de Données

Postuler Maintenant

Trouver des Emplois à Distance Similaires

Recevoir des emails pour des emplois à distance

📊 Vérifiez votre score de CV pour ce poste

Améliorez vos chances d'obtenir un entretien en vérifiant votre score de CV avant de postuler.

Télécharger le CV

Verista, Inc.

Site WebLinkedInTous les Emplois

501 - 1000 employés

🧬 Biotechnologie

💊 Pharmaceutique

⚕️ Assurance santé

Biotechnology • Pharmaceuticals • Healthcare Insurance

Verista, Inc. est un prestataire de services spécialisé dans les solutions pour les secteurs des sciences de la vie, de la biotechnologie, de l'industrie pharmaceutique et des dispositifs médicaux. Ils offrent leur expertise dans des domaines tels que la mise en service, la qualification et la validation, l'intégration de systèmes et de vision, les solutions technologiques, les analyses de données et la stratégie, la cybersécurité, la transformation numérique, la conformité réglementaire et la gestion des infrastructures. Verista excelle dans la fourniture de services gérés, de gestion de programmes et de projets, et de stratégie numérique pour assurer la qualité et la conformité tout au long du cycle de vie des produits. Leur focus sur l'engagement personnalisé et la communication efficace en fait un partenaire privilégié parmi les plus grandes entreprises des sciences de la vie à travers le monde.

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

🎯 Exigences

• 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

🏖️ Avantages

• 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