Senior Computer System Validation Specialist

Rochester Regional Health

2d•$105,000 - $130,000•Remote

About The Position

The Senior CSV/CSA Specialist leads risk-based validation and assurance activities for GxP-regulated computerized systems throughout their lifecycle. The role provides technical leadership in validation strategy, execution, quality review, audit and inspection readiness, and serves as a subject matter expert in CSV/CSA, SDLC, data integrity, electronic records and signatures, and regulatory requirements. The position also mentors junior CSV/CSA team members. The role supports computerized systems from procurement and implementation through operational use, change control, periodic review, migration, archival, and retirement. It provides IT Quality and Compliance oversight, ensures systems remain in a state of control, and supports audits, inspections, CAPAs, deviations, and remediation. The position is remote, with East Coast candidates preferred, and has a 40-hour Monday–Friday daytime schedule.

Requirements

Bachelor’s degree in Computer Science, Information Systems, Engineering, Life Sciences, Quality, or a related field, or an equivalent combination of education and relevant experience.
At least 5 years of experience in CSV, CSA, IT quality, software validation, change control, SDLC, or GxP computerized systems.
Strong technical writing, documentation review, inspection-readiness, analytical, prioritization, facilitation, and communication skills.
Ability to interpret regulatory expectations and apply them pragmatically to system risk, intended use, and business impact.
Ability to lead complex validation activities across multiple systems, projects, stakeholders, and priorities.

Nice To Haves

Strong knowledge of computerized system validation, CSA, GAMP 5, SDLC, GxP, 21 CFR Part 11, EU Annex 11, data integrity, and electronic records/signature expectations.
Strong working knowledge of validation lifecycle deliverables and risk-based validation practices.
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.

Responsibilities

Lead planning, execution, review, and approval of validation and assurance deliverables for GxP systems, upgrades, integrations, infrastructure changes, software changes, and system retirements.
Determine appropriate validation or assurance rigor using risk-based principles aligned with GAMP 5, CSA, data integrity, electronic records and signatures, and applicable GxP expectations.
Lead or review system risk assessments, validation strategy assessments, supplier/vendor assessments, impact assessments, and validation planning decisions.
Ensure validation strategies are proportionate to system risk, intended use, business process impact, patient or subject safety, product quality, data integrity, and regulatory impact.
Author, review, or approve validation lifecycle deliverables, including risk assessments, validation or assurance plans, requirements and specifications, testing protocols and evidence, traceability matrices, summary reports, periodic reviews, change assessments, and migration, archival, decommissioning, and retirement documentation.
Ensure validation documentation is complete, accurate, traceable, reviewable, and inspection-ready.
Provide quality and technical review of deliverables prepared by project teams, IT system owners, vendors, and less senior CSV/CSA resources.
Provide IT Quality and Compliance oversight for computerized systems, SDLC activities, validation and change-control deliverables, and system lifecycle processes.
Support internal, external, client, and regulatory audits and inspections, as well as audit responses, CAPAs, deviations, and remediation plans related to computerized systems.
Identify compliance gaps, documentation weaknesses, lifecycle risks, and process-improvement opportunities.
Partner with Quality Assurance to resolve validation-related observations, audit findings, deviations, CAPAs, and inspection commitments.
Support system lifecycle activities including procurement, implementation, configuration, validation, operations, change control, periodic review, incident/deviation support, migration, archival, and retirement.
Maintain validated systems 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 GxP IT 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 the development and improvement of validation procedures, forms, templates, guidance documents, training materials, metrics, and operating rhythms.
Promote consistent application of risk-based validation, CSA, supplier reliance, testing strategy, and lifecycle documentation practices.
Facilitate cross-functional meetings and communications regarding validation strategy, compliance expectations, audit readiness, and lifecycle deliverables.
Perform other duties as assigned, including duties reasonably required and commensurate with the role's skills, experience, and responsibility level.