Senior Computer System Validation Specialist

Job not on LinkedIn

🔥 0 minutes ago

🗽 New York – Remote

🗽 New York – Remote

💵 $105k - $130k / year

⏰ Full Time

🟠 Senior

👻 Ghost score 0%

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Rochester Regional Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

⚕️ Healthcare Insurance

📚 Education

Healthcare • Healthcare Insurance • Education

Rochester Regional Health is an integrated health services organization serving the people of Western New York. It operates multiple hospitals and healthcare facilities, providing a wide range of healthcare services, including emergency care, primary care, specialty clinics, and urgent care. The organization is committed to medical education and research, offering training programs, residencies, and clinical trials. Rochester Regional Health focuses on comprehensive care with emphasis on treating patients respectfully and meeting their diverse medical needs across all stages of life.

📋 Description

• 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

🎯 Requirements

• 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