Must Have SAP Experience
Software Validation

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 Sol

📌 SAP Validation Engineer (Ciudad Juárez)
🏢 Bepc
📍 Ciudad Juárez