CSV Validation Engineer

Stefanini LATAM; Quebec; On-site; MXN 600,000 - 1,000,000; Full time

Job summary

Stefanini LATAM is seeking a senior CSV Validation Engineer to lead end-to-end validation of GxP-regulated computerized systems across enterprise, laboratory, manufacturing and quality environments.

The role focuses on risk-based validation planning, authoring URS,IQ/OQ/PQ protocols, validation reports, traceability matrices, and data-integrity reviews with hands-on execution and cross-functional collaboration.

Qualifications

• 5+ years of hands-on Computer System Validation in a GxP-regulated environment (pharma, biotech, or medical-device).
• Strong technical writing skills; ability to produce audit-ready documentation.

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 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.

Job description

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 environment (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.