Senior Computer System Validation Specialist

This is a fully remote position, open to applicants in New York.

📋 Description

• Oversee risk-based validation and assurance tasks for GxP-regulated computerized systems throughout their entire lifecycle.

• Offer technical leadership in validation strategies, execution, quality assessments, and preparation for audits and inspections.

• Act as a subject matter expert in CSV/CSA, SDLC, data integrity, electronic records/signatures, and regulatory standards.

• Create, review, or approve validation lifecycle documents, including risk assessments, validation or assurance plans, specifications, testing protocols, UAT evidence, traceability matrices, summary reports, periodic reviews, change impact assessments, migration, archival, decommissioning, and retirement documentation.

• Provide oversight in IT Quality and Compliance for computerized systems, SDLC tasks, validation documents, change controls, and lifecycle processes.

• Assist with audits, inspections, audit responses, CAPAs, deviations, remediation plans, and validation-related findings.

• Aid in procurement, implementation, configuration, validation, operational usage, change control, periodic review, incident/deviation support, migration, archival, and retirement activities.

• Ensure that validated systems are maintained in a controlled state through change assessments, regression testing, periodic reviews, access/security checks, backup/restore evaluations, data integrity assessments, and documentation upkeep.

• Offer senior-level analysis and insights for change controls, impact assessments, validation strategy choices, test planning, evidence examination, and release preparedness.

• Provide technical leadership, coaching, and mentorship to CSV/CSA Specialists and cross-functional project teams.

• Assist in the development and enhancement of validation procedures, templates, guidance documents, training materials, metrics, and operational rhythms.

• Facilitate cross-functional meetings and communications regarding validation strategies, compliance expectations, audit readiness, and lifecycle deliverables.

• Perform additional duties as assigned.

⛳️ 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.

• 5+ years of experience in CSV, CSA, IT quality, software validation, change control, SDLC, or GxP computerized systems.

• In-depth 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 understanding of validation lifecycle deliverables and risk-based validation methodologies.

• Capable of interpreting regulatory requirements and applying them practically to system risks, intended uses, and business impacts.

• Excellent technical writing, documentation review, inspection-readiness, analytical, prioritization, facilitation, and communication skills.

• Proven experience leading validation strategies and deliverable execution for laboratory, quality, clinical, enterprise, infrastructure, data, or integration systems.

• Experience assisting with audits, inspections, CAPAs, deviations, remediation efforts, SDLC reviews, change controls, testing evidence, data integrity measures, and lifecycle documentation.

• Background in mentoring or providing technical guidance to junior validation or quality personnel.

• Ability to manage complex validation initiatives across multiple systems, projects, stakeholders, and priorities.

• Capability to work remotely; preference for East Coast candidates.

🏝️ Benefits

• Comprehensive health benefits package.

• Flexible working hours and remote work options.

• Opportunities for professional development and growth.

• Collaborative and supportive work environment.