KEY RESPONSIBILITIES:
-Lead and execute SAP validation activities, ensuring compliance with CSV, SDLC, GMP, and applicable regulatory requirements.
-Develop, review, and maintain validation documentation, including Validation Plans, User Requirements Specifications (URS), Functional Specifications (FS), Risk Assessments, IQ/OQ protocols, Traceability Matrices, and Final Reports.
-Collaborate with IT, Quality, Manufacturing, Supply Chain, and Business stakeholders to ensure successful deployment and validation of SAP solutions.
-Manage deviations, discrepancies, CAPAs, and change control activities associated with SAP implementations.
-Utilize tools such as JIRA, ALM, Azure DevOps, Solution Manager, or equivalent platforms to manage testing and validation activities.
-Support audits and inspections by providing validation evidence and ensuring compliance with FDA, GxP, and company quality standards.
-Provide technical guidance and mentorship to junior validation engineers and project team member

BASIC QUALIFICATIONS:
-Bachelor's degree in Computer Science, Engineering,



Information Systems, or related field.
-Minimum of 3 years of experience in SAP validation, SAP testing, SAP implementation, or related areas.
-Experience working in regulated industries such as Medical Devices, Pharmaceutical, Biotechnology, or Life Sciences.
-Strong analytical, troubleshooting, and problem-solving skills.
-Proactive: Identifies risks and issues early and drives resolution.
-Results-Oriented: Focuses on achieving project milestones and business objectives.
-Advanced proficiency in English.

TECHNICAL SKILLS:
-Strong understanding of Computer System Validation (CSV) and Software Development Lifecycle (SDLC).
-Experience validating SAP implementations, upgrades, migrations, or integrations.
-Familiarity with FDA 21 CFR Part 11, 21 CFR Part 820, EU MDR, GMP, GDP, and GAMP 5 principles.
-Experience with defect management and testing tools such as JIRA, SAP Solution Manager, ALM, or Azure

📌 Ingeniero de Validación de Software (Ciudad Juárez)
🏢 Bepc
📍 Ciudad Juárez