Senior Software Validation Engineer - Quality & Compliance

jabil; Ecatepec de Morelos; On-site; MXN 600,000 - 900,000; Full time

Job summary

Jabil seeks a Software Validation Engineering professional to lead the Validation Master Plan for software validations and revalidations. The role requires ensuring compliance with ISO 13485, CFR Part 820, and GAMP 5, while acting as SME for SAP and MES systems.

Responsibilities include CAPA leadership, audits, and mentoring junior engineers. Based in Ecatepec de Morelos, Mexico, the role supports test script creation and process validations per customer and Nypro requirements, contributing to

Qualifications

• Experience in software validation within regulated environments (ISO 13485, CFR Part 820).
• Knowledge of CAPA, NCMRs, and internal audits.
• Familiarity with SAP and MES systems as validation targets.

Responsibilities

• Administrate the Validation Master Plan for Validations and Revalidations.
• Maintain Plant Validation Master Plan for Software and protocol report templates.
• Lead CAPA, NCMRs, and software validation-related complaints.
• Perform and support test scripts creation and software validations.
• Conduct internal audits and support corrective actions per ISO/GAMP requirements.

Skills

Software validation

Quality engineering

Regulatory compliance

CAPA leadership

Tools

SAP

MES

GAMP 5

Job description

Jabil seeks a Software Validation Engineering professional to lead the Validation Master Plan for software validations and revalidations. The role requires ensuring compliance with ISO 13485, CFR Part 820, and GAMP 5, while acting as SME for SAP and MES systems.

Responsibilities include CAPA leadership, audits, and mentoring junior engineers. Based in Ecatepec de Morelos, Mexico, the role supports test script creation and process validations per customer and Nypro requirements, contributing to