Senior Computer System Validation Specialist

🔥 3 horas atrás

🗽 New York – Remoto

🗽 New York – Remote

💵 $105.000 - $130.000 / ano

⏰ Tempo Integral

🟠 Sênior

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ACM Global Laboratories

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

🏥 Saúde

💼 Consultoria

📦 Logística

Healthcare • Consulting • Logistics

ACM Global Laboratories é um fornecedor líder de serviços de teste para ensaios clínicos, apoiando testes clínicos globalmente em mais de 65 países. A empresa oferece uma gama de serviços bioanalíticos, incluindo análise de pequenas e grandes moléculas, análise de biomarcadores e várias soluções de testes laboratoriais, como testes de segurança de rotina, citometria de fluxo e rastreamento avançado de amostras. ACM Global Laboratories é reconhecida por sua experiência em serviços de bioanálise e toxicologia, garantindo alta sensibilidade e precisão nas medições de fármacos e metabólitos em diversas amostras biológicas. A empresa é dedicada a fornecer insights clínicos acionáveis e serviços de toxicologia confiáveis para provedores de saúde, colaborando com ensaios clínicos para otimizar projetos de desenvolvimento através de serviços laboratoriais de ponta, gerenciamento de amostras e logística global.

Descrição

• Lead risk-based validation and assurance activities for GxP-regulated computerized systems throughout their lifecycle • Provide technical leadership in validation strategy, execution, quality review, audit and inspection readiness • Serve as a subject matter expert in CSV/CSA, SDLC, data integrity, electronic records/signatures, and regulatory requirements • Author, review, or approve validation lifecycle deliverables, including risk assessments, validation or assurance plans, specifications, testing protocols, UAT evidence, traceability matrices, summary reports, periodic reviews, change impact assessments, migration, archival, decommissioning, and retirement documentation • Provide IT Quality and Compliance oversight for computerized systems, SDLC activities, validation deliverables, change controls, and lifecycle processes • Support audits, inspections, audit responses, CAPAs, deviations, remediation plans, and validation-related observations • Support procurement, implementation, configuration, validation, operational use, change control, periodic review, incident/deviation support, migration, archival, and retirement • Ensure validated systems remain in a state of control through change assessment, regression testing, periodic review, access/security review, backup/restore review, data integrity review, and documentation maintenance • Provide senior-level review and guidance for change controls, impact assessments, validation strategy decisions, test planning, evidence review, and release readiness • Provide technical leadership, coaching, and mentoring to CSV/CSA Specialists and cross-functional project teams • Support development and improvement of validation procedures, templates, guidance documents, training materials, metrics, and operating rhythms • Facilitate cross-functional meetings and communications related to validation strategy, compliance expectations, audit readiness, and lifecycle deliverables • Perform other duties as assigned

🎯 Requisitos

• Bachelor’s degree in Computer Science, Information Systems, Engineering, Life Sciences, Quality, or related field OR equivalent combination of education and relevant experience • 5+ years of CSV, CSA, IT quality, software validation, change control, SDLC, or GxP computerized systems experience • Strong knowledge of computerized system validation, CSA, GAMP 5, SDLC, GxP, 21 CFR Part 11, EU Annex 11, data integrity, and e-record/e-signature expectations • Strong working knowledge of validation lifecycle deliverables and risk-based validation practices • Ability to interpret regulatory expectations and apply them pragmatically to system risk, intended use, and business impact • Strong technical writing, documentation review, inspection-readiness, analytical, prioritization, facilitation, and communication skills • Experience leading validation strategy and deliverable execution for laboratory, quality, clinical, enterprise, infrastructure, data, or integration systems • Experience supporting audits, inspections, CAPAs, deviations, remediation activities, SDLC reviews, change controls, testing evidence, data integrity controls, and lifecycle records • Experience mentoring or providing technical guidance to less senior validation or quality resources • Ability to lead complex validation activities across multiple systems, projects, stakeholders, and priorities • Ability to work remotely; East Coast preferred