BEPC Inc. provides Specialized Engineering Solutions and IT Project Management services to Fortune 500 companies in the Life Science and Technology industries. BEPC Mexico, a division of BEPC Incorporated, provides and manages consulting services for Automotive and Medical device companies throughout Mexico and around the globe. We are seeking a highly skilled and experienced Software Validation Engineer (SAP) to join our dynamic team. The ideal candidate will possess a strong blend of technical expertise and soft skills, ensuring the reliability and quality of our software products. 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. Support SAP implementation, migration, upgrade, and enhancement projects across modules such as SAP ECC, S/4HANA, MM, PP, WM, QM, SD, or related business applications. 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. Participate in risk assessments and validation strategy development for SAP systems and integrated applications. 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 members. 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 DevOps. Understanding system integrations between SAP, MES, LIMS, PLM, WMS, and other enterprise applications. #J-18808-Ljbffr
Software Validation Engineer (Sap)
BEPC INC. - BUSINESS EXCELLENCE PROFESSIONAL CONSULTING
Ciudad Juárez, Ciudad Juárez
Publicado hace 4 días
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