SOFTWARE VALIDATION ENGINEER III / QUALITY ENGINEER III

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

At Jabil (NYSE: JBL), we are proud to be a trusted partner for the world's top brands, offering comprehensive engineering, supply chain, and manufacturing solutions. With 60 years of experience across industries and a vast network of over 100 sites worldwide, Jabil combines global reach with local expertise to deliver both scalable and customized solutions. Our commitment extends beyond business success as we strive to build sustainable processes that minimize environmental impact and foster vibrant and diverse communities around the globe.

Administrate the Validation Master Plan for Validations and Revalidations.

• Assure that the requirements from ISO 13485, QSR Part 820 and 11 related with control of Softwares and Validation Master Plan for Software are properly followed.
• Maintain the Plant Validation Master Plan for Software’s and the templates for protocol reports in the System.
• Perform the annual review to the Plant Validation Master Plan for Softwares.
• SME for SAP and MES systems.
• Participate in the Management Review given status , trending related to the Plant Validation Master Plan for Software.
• Follow the Risk Analysis program for Software Validations.
• Perform training in Validation requirements under a regulated environment following CFR Part 820, 11, ISO 13485 and GAMP 5.
• Leader for CAPA’s, NCMRs and complaints related to the Software Validation.
• Perform and give support in the test scripts creation.
• Audits quality systems for deficiency identification and correction.
• Assists in the process for ensuring that corrective actions (CAPA) are completed in accordance with relevant ISO requirements (ISO 9001 and ISO 13485), Nypro Advance Problem Solving methods, and that documentation is complete and compliant with requirements.
• May provide direction and mentoring to less experienced Software Validations Engineers.
• Demonstrated competence in Software Validation Quality Engineering body of knowledge.
• Writes, reviews, approves process validations/qualifications related to Software Validations in accordance with Nypro and customer requirements.
• Give support in the Audits from 1st, 2nd, 3th parties.
• Be part of the Internal Audit Team.
• Support all company safety and quality programs and initiatives.
• May perform other duties and responsibilities as assigned.
• Provide support to all Safety, Health and Environment (EHS) programs and initiatives in order to support our zero accident culture.

Jabil, including its subsidiaries, is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identity, age, disability, genetic information, veteran status, or any other characteristic protected by law.

Accessibility Accommodation

If you are a qualified individual with a disability, you have the right to request a reasonable accommodation if you are unable or limited in your ability to use or access Jabil.com/Careers site as a result of your disability. You can request a reasonable accommodation by sending an e-mail to [e-mail] with the nature of your request and contact information. Please do not direct any other general employment related questions to this e‑mail. Please note that only those inquiries concerning a request for reasonable accommodation will be responded to.