? The Role 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.

📌 CSV Validation Engineer (México)
🏢 Stefanini LATAM
📍 México