Senior Computer System Validation Specialist

Rochester Regional Health

. Lead planning, execution, review, and approval of validation and assurance deliverables for new GxP systems, upgrades, integrations, infrastructure changes, software changes, and system retirements .

Posted 10/5/2026full-timeRemote • New York • United StatesSenior💰 $105,000 - $130,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in Computerized System Validation (CSV) and Change Control processes, ensuring compliance with GxP regulations and industry standards. Proficient in leading validation strategy, technical writing, and cross-functional collaboration to maintain system integrity and audit readiness.

Highest-signal resume keywords

Computerized System Validation (CSV)GxP ComplianceGAMP 5 KnowledgeValidation Lifecycle DeliverablesTechnical Writing

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Change ControlSoftware ValidationSDLCRisk-Based Validation PracticesData IntegrityValidation PlansTesting ProtocolsImpact AssessmentsUAT EvidenceTraceability Matrices

Soft Skills

Analytical SkillsCommunication SkillsFacilitation SkillsPrioritization SkillsMentoring

Industry Keywords

21 CFR Part 11EU Annex 11Electronic Records/SignaturesAudit ReadinessCAPAsDeviationsRemediation PlansInspection-ReadinessCross-Functional CollaborationLifecycle Records

Tech Stack

Tools & technologies

SDLC

About the role

Key responsibilities & impact

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

What you’ll need

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