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, while serving as a subject matter expert in CSV/CSA, SDLC, data integrity, electronic records/signatures, and regulatory requirements. The position also provides mentorship to junior CSV/CSA team members.

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+ yrs CSV, CSA, IT quality, software validation, change control, SDLC, or GxP computerized systems experience

Nice To Haves

• 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.

Responsibilities

• Lead planning, execution, review, and approval of validation and assurance deliverables for new GxP systems, system 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, e-record/e-signature, 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/subject safety, product quality, data integrity, and regulatory impact.
• Author, review, or approve validation lifecycle deliverables, including system risk assessments, validation plans or assurance plans, URS, functional/design/configuration specifications, IQ/OQ/PQ or functional testing protocols, regression testing, UAT evidence, traceability matrices, validation summary reports, periodic reviews, change impact assessments, data 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 deliverables, change control deliverables, and system lifecycle processes.
• Support internal audits, external audits, client audits, regulatory inspections, 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 lifecycle activities including 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 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 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 related to validation strategy, compliance expectations, audit readiness, and lifecycle deliverables.
• Perform other duties as assigned.

Benefits

• The posted pay range is a good faith representation of potential base pay for this position. It may be modified in the future and eligible for additional pay components. Individual annual salaries/hourly rates could vary based on position details and FTE. Pay is determined by considering factors including, but not limited to, experience, relevant qualifications, specialty, internal equity, locations, and contracts.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior