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.

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 DevOps.
- Understanding system integrations between SAP, MES, LIMS, PLM, WMS, and other enterprise applications.

MXOPS

Tipo de puesto: Jornada completa

Sueldo: $100.00 - $200.00 al mes

Beneficios:

- Seguro de gastos médicos mayores
- Seguro dental

Lugar de trabajo: Empleo presencial

📌 SAP (Software Validation) (México)
🏢 Bepc
📍 México