Senior Computer System Validation Specialist

Vaga não está no LinkedIn

🔥 49 minutos atrás

🗽 New York – Remoto

🗽 New York – Remote

💵 $105.000 - $130.000 / ano

⏰ Tempo Integral

🟠 Sênior

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Rochester Regional Health

SiteLinkedInTodas as Vagas

10.000+ funcionários

🏥 Saúde

⚕️ Seguro de Saúde

📚 Educação

Healthcare • Healthcare Insurance • Education

Rochester Regional Health é uma organização integrada de serviços de saúde que atende a população do oeste de Nova York. Opera múltiplos hospitais e unidades de saúde, oferecendo uma ampla gama de serviços de saúde, incluindo atendimento de emergência, cuidados primários, clínicas especializadas e atendimento de urgência. A organização é comprometida com a educação médica e a pesquisa, oferecendo programas de treinamento, residências e ensaios clínicos. Rochester Regional Health foca em cuidados abrangentes com ênfase no tratamento respeitoso dos pacientes e na satisfação de suas diversas necessidades médicas em todas as fases da vida.

Descrição

• Lead planning, execution, review, and approval of validation and assurance deliverables for new GxP systems, upgrades, integrations, infrastructure changes, software changes, and system retirements • Determine validation or assurance rigor using risk-based principles aligned with GAMP 5, CSA, data integrity, electronic records/signatures, and applicable GxP expectations • Lead or review system risk assessments, validation strategy assessments, supplier/vendor assessments, impact assessments, and validation planning decisions • Author, review, or approve validation lifecycle deliverables, including validation plans, URS, specifications, testing protocols, regression testing, 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 system lifecycle processes • Support audits, inspections, audit responses, CAPAs, deviations, and remediation plans related to computerized systems • 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

🎯 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