Senior Computer System Validation Specialist

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

📋 Description

• Oversee the planning, execution, assessment, and approval of validation and assurance deliverables for new GxP systems, upgrades, integrations, infrastructure modifications, software changes, and system decommissioning.

• Establish the level of validation or assurance required using risk-based principles that align with GAMP 5, CSA, data integrity, electronic records/signatures, and relevant GxP standards.

• Lead or evaluate system risk assessments, validation strategy evaluations, supplier/vendor assessments, impact analyses, and validation planning decisions.

• Draft, review, or authorize validation lifecycle documents, including validation plans, User Requirements Specifications (URS), specifications, testing protocols, regression testing, User Acceptance 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, Software Development Life Cycle (SDLC) activities, validation outputs, change controls, and system lifecycle processes.

• Assist with audits, inspections, audit responses, Corrective and Preventive Actions (CAPAs), deviations, and remediation plans related to computerized systems.

• Support procurement, implementation, configuration, validation, operational use, change control, periodic review, incident/deviation management, migration, archival, and retirement processes.

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

• Offer senior-level review and guidance for change controls, impact assessments, validation strategy decisions, test planning, evidence evaluation, and release readiness.

• 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 concerning validation strategies, compliance expectations, audit preparedness, and lifecycle deliverables.

⛳️ 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.

• A minimum of 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 electronic record/e-signature requirements.

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

• Capability to interpret regulatory expectations and apply them effectively to system risks, intended use, and business implications.

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

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

• Familiarity with supporting audits, inspections, CAPAs, deviations, remediation activities, SDLC evaluations, change controls, testing evidence, data integrity controls, and lifecycle records.

• Experience mentoring or providing technical guidance to junior validation or quality team members.

• Proven ability to manage complex validation activities across multiple systems, projects, stakeholders, and priorities.

🏝️ Benefits

• Comprehensive health and wellness plans.

• Competitive salary and performance-based incentives.

• Opportunities for professional development and advancement.

• Flexible work arrangements.

• A collaborative and innovative work environment.