Senior Computer System Validation Specialist

Rochester Regional Health; City of Rochester (NY); À distance; USD 105 000 - 130 000; Plein temps

Résumé du poste

Rochester Regional Health is seeking a Senior CSV/CSA Specialist to lead risk-based validation and assurance of GxP computerized systems across their lifecycle. The role provides technical leadership in validation strategy, data integrity, audit readiness, and regulatory compliance, while mentoring junior CSV/CSA staff.

The position is remote with East Coast preference, offering 40 hours per week. You will collaborate with IT and Quality teams to support audits, inspections, and lifecycle

Qualifications

• Bachelor's degree or equivalent in a related field.
• 5+ years of CSV/CSA, IT quality, software validation, change control, SDLC, or GxP systems experience.

Responsabilités

• Lead planning, execution, review, and approval of validation deliverables for new GxP systems and upgrades.
• Conduct risk assessments, validation strategy reviews, and supplier assessments.
• Ensure validation documentation is complete, traceable, and inspection-ready.
• Provide technical review and mentorship to CSV/CSA team members.

Connaissances

CSV/CSA experience

Regulatory compliance

IT quality

Formation

Bachelor's degree in CS/IS/Engineering/Life Sciences/Quality or related field

Description du poste

Description

Job Title: Senior CSV/ CSA Specialist Department: Information Technology Location: Remote, East Coast PreferredHours Per Week: 40 Schedule: Days, Monday - Friday

SUMMARY

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.

RESPONSIBILTIES

Validation and Assurance Strategy: 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. CSV/CSA Deliverables: 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. IT Quality and Compliance Oversight: 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. System Lifecycle and Change Support: 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. Leadership, Mentoring, and Continuous Improvement: 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.This job description is not intended to be exhaustive. The employee may be required to undertake any other duties that are reasonably required and are commensurate with the skills, experience and level of responsibility of the role.

MINIMUM QUALIFICATIONS

Bachelor's degree in Computer Science, Information Systems, Engineering, Life Sciences, Quality, or related fieldOR Equivalent combination of education and relevant experience 5+ yrs CSV, CSA, IT quality, software validation, change control, SDLC, or GxP computerized systems experience

PREFERRED QUALIFICATIONS

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 resourcesAbility to lead complex validation activities across multiple systems, projects, stakeholders, and priorities.

PHYSICAL REQUIREMENTS

Sedentary - Sedentary roles are primarily office-based and require prolonged sitting (67-100% of the workday) with minimal physical effort and lifting limited to under 10 lbs. Fine motor skills are necessary for computer work, writing, and telephone use, supported by clear visual and auditory ability. Cognitive and emotional demands are high due to extended concentration, frequent interruptions, independent decision-making, and information processing. Although physical exposure is low, administrative areas within healthcare environments may occasionally involve contact with infectious agents. Some roles may require flexible hours, TB screening, or a valid driver's license.

PAY RANGE

$105,000.00 - $130,000.00

The listed base pay range is a good faith representation of current potential base pay for successful applicants. It may be modified in the future. Pay is determined by factors including experience, clinical licensure date, relevant qualifications, specialty, internal equity, location, and contracts.

Rochester Regional Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, sex (including pregnancy, childbirth, and related medical conditions), sexual orientation, gender identity or expression, national origin, age, disability, predisposing genetic characteristics, marital or familial status, military or veteran status, citizenship or immigration status, or any other characteristic protected by federal, state, or local law.