Computer Systems Validation Engineer

Vaga não está no LinkedIn

🕒 5 dias atrás

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $150.000 - $178.000 / ano

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

👷🏻‍♀️ Engenheiro

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Praxis

SiteLinkedInTodas as Vagas

11 - 50 funcionários

Fundada em 2002

🏥 Saúde

💼 Consultoria

📦 Logística

Healthcare • Consulting • Logistics

A Praxis é uma empresa dedicada a conectar pacientes com oportunidades significativas de ensaios clínicos. Com foco na criação de programas de recrutamento personalizados, a Praxis utiliza uma variedade de ferramentas especializadas e vasta experiência em diversas áreas terapêuticas para garantir que alcancem os pacientes certos em todo o mundo. Estabelecida em 2002, a empresa enfatiza a importância do engajamento do paciente e utiliza insights sofisticados de dados para aprimorar a jornada do paciente na pesquisa clínica.

Descrição

• Lead and scale the Computer System Validation capability across IT, defining the validation strategy, operating model, standards, and risk-based approach • Build and develop the CSV team, including hiring, onboarding, mentoring, and developing additional CSV Engineers • Author, review, execute, and maintain validation lifecycle deliverables, including validation plans, requirements, risk assessments, specifications, test protocols and scripts, traceability matrices, and validation summary reports • Determine validation scope, test depth, and evidence requirements using a documented risk-based approach • Execute or coordinate qualification and verification activities, including installation, operational, performance, user acceptance, and other risk-based assurance testing • Assess changes to validated systems, determine validation impact, support regression testing, and ensure approved change control implementation • Perform validation maintenance, periodic reviews, access and audit-trail reviews, revalidation assessments, and retirement or decommissioning support • Support investigation and resolution of validation deviations, test exceptions, incidents, and compliance gaps, contributing to CAPAs when appropriate • Prepare validation records and evidence packages for audits, regulatory inspections, and due-diligence activities • Collaborate with system owners, business process owners, Quality, IT, technical teams, and vendors • Continuously improve validation procedures, templates, standards, metrics, and training materials • Use approved automation and AI-assisted tools to improve validation efficiency while independently reviewing outputs

🎯 Requisitos

• Bachelor's degree in engineering, computer science, information systems, life sciences, or a related discipline; equivalent relevant experience may be considered • Significant experience working in biotechnology, pharmaceutical, medical device, healthcare, or another regulated environment • Strong experience with Computer System Validation, Computer Software Assurance, quality systems, and data integrity principles • Demonstrated ability to lead validation activities across multiple computerized systems and projects • Experience supporting regulatory inspections, audits, validation assessments, and quality-system documentation • Strong knowledge of GxP requirements, GAMP 5, risk-based CSV/CSA principles, 21 CFR Part 11, EU Annex 11, ALCOA+ data integrity principles, change control, deviations, CAPA, and document control • Experience with functional risk assessments, requirements traceability, supplier assessments, change control, deviations, CAPA, and periodic review • Experience authoring, reviewing, or executing IQ, OQ, PQ, UAT, or equivalent risk-based verification documentation • Familiarity with scripting, SQL, test automation, validation automation, electronic document management, quality management, or issue-tracking tools is advantageous • Regular use of a computer, devices, or other office equipment, clear communication, and occasional movement

🏖️ Benefícios

• Equal opportunity employer • Reasonable accommodations for individuals with disabilities • Occasional travel as needed