The CSV Validation Engineer will serve as a senior subject‑matter expert responsible for the end‑to‑end validation of GxP‑regulated computerized systems . This hands‑on role focuses on assessing validation status , defining risk‑based validation strategies , and authoring all required documentation —from discovery through execution—across a diverse portfolio of enterprise, laboratory, manufacturing, and quality systems

Key Responsibilities

Lead risk‑based validation planning and execution for GxP systems throughout their lifecycle. Author core validation deliverables (Validation Plans, URS, Risk Assessments, IQ/OQ/PQ protocols & reports, Traceability Matrices, Validation Summary Reports, Decommissioning Plans).

Conduct impact assessments for system changes, incidents, upgrades, and releases; generate Software Compliance Assessments and Change Requests.

Perform periodic reviews, data‑integrity assessments, and audit‑trail evaluations covering the full data lifecycle.

Manage test execution documentation, evidence collection, and, when required, review source code or configuration. Provide CSV expertise during vendor selection, qualification, and ongoing vendor‑managed validation activities.

Advise project teams, system owners, IT, and quality stakeholders on GxP validation requirements and best practices.

Support decommissioning of retired systems and closure of associated validation records.



Utilize Jira for test management, defect tracking, requirements traceability, and project coordination.

Align all work with the organization’s validation templates, SDLC, and quality system standards.

Job Requirements

5 + years of hands‑on Computer System Validation experience in a GxP‑regulated setting (pharma, biotech, or medical‑device).

Proven track record of personally authoring validation deliverables such as URS, Risk Assessments,IQ/OQ/PQ protocols, Traceability Matrices, and Validation Summary Reports. Direct experience leading periodic system reviews and conducting data‑integrity/audit‑trail assessments.

Demonstrated ability to evaluate and document the impact of system changes, upgrades, and incidents on validated state.

Working fluency in GAMP 5 categories, 21 CFR Part 11, and EU GMP Annex 11; comfortable discussing ICH guidelines and data‑integrity principles without reference material. Strong technical writing skills; ability to produce clear, audit‑ready documentation independently.

Bachelor’s degree in Computer Science, Information Technology, Engineering, or a related discipline, or equivalent professional experience.

Advanced English proficiency (C1 level) – required for documentation, stakeholder communication, and regulatory interactions.

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📌 CSV Validation Engineer (Quebec City)
🏢 Stefanini LATAM
📍 Quebec City