At Jabil we strive to make ANYTHING POSSIBLE and EVERYTHING BETTER. With over 260,000 diverse, talented and dedicated employees across 100 locations in 30 countries, our vision is to be the most technologically advanced and trusted manufacturing solutions provider. We combine an unmatched breadth and depth of end-market experience, technical and design capabilities, manufacturing know-how, supply chain insights and global product management expertise to enable success for the world’s leading brands. We are driven by a common purpose to make a positive impact for each other, our communities, and the environment. JOB SUMMARY To supervise and administrate the validations of the Computerized Systems. Coordinate and Maintain the Validation Master Plan including procedures, validation templates and revalidations. Administrate the Software PLCs and Computerized Systems Inventory for the Plant, following the requirements in CFR Part 820 and 11. ESSENTIAL DUTIES AND RESPONSIBILITIES - 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. JOB QUALIFICATIONS KNOWLEDGE REQUIREMENTS - BS degree or equivalent in Industrial Engineer or Technologies Information career prefered - 4+ years of experience - Or an equivalent combination of education, training or experience. - Good English Knowledge 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 identify, age, disability, genetic information, veteran status, or any other characteristic protected by law.