Must Have SAP Experience
Software Validation
**KEY RESPONSIBILITIES**:
**Lead and execute SAP validation activities, ensuring compliance with CSV, SDLC, GMP, and applicable regulatory requirements.
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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.
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**Utilize tools such as JIRA, ALM, Azure DevOps, Solution Manager, or equivalent platforms to manage testing and validation activities.
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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.
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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.
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Strong analytical, troubleshooting, and problem-solving skills.
**Proactive: Identifies risks and issues early and drives resolution.
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Results-Oriented: Focuses on achieving project milestones and business objectives.
**Advanced proficiency in English.
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**TECHNICAL SKILLS**:
**Strong understanding of Computer System Validation (CSV) and Software Development Lifecycle (SDLC).
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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 DevOps.
MXOPS
Pay: $****** - $****** per month
Work Location: In person

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