Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities. * This is a Quality Engineering position with validation activities focused on executing and verifying the maintenance of the validated state of site computerized systems, ensuring that systems function efficiently and correctly to produce quality products. * Responsible for executing validations, monitoring programs, and remediation plans for computerized systems at the plant, in compliance with internal policies and international standards, as well as strengthening continuous improvement in data integrity processes. 1. Monitor compliance with regulatory requirements regarding data integrity and validation of computerized systems (CFR 21 part 11, Annex 11 of EC, ISO-13485). 2. Act as part of the local data governance team and SME regarding data integrity and validation of computerized systems. 3. Perform validation of computerized systems including applications, Cloud Systems, ERP, controllers of production equipment, laboratory equipment, among others. 4. Prepare corresponding validation protocols and reports. 5. Comply with the current Master Plan for Validation of Computerized Systems. 6. Collaborate with area and system owners, as well as with IT, to ensure compliance with the corporate strategy for data management and regulatory compliance in data integrity. 7. Conduct follow-up audits for electronic records management and review the maintenance of the validated state of computerized systems. 8. Track remediation plans and risk mitigation actions for data in computerized systems. 9. Provide technical support to users and system owners for the design, maintenance, electronic and electrical characteristics, and safety elements of plant computerized systems. 10. Participate in decision-making structures related to regulatory compliance and quality standards in all operations described above. 11. Develop, modify, and maintain Standard Operating Procedures (SOPs) for your area. 12. Support additional activities required by your supervisor as part of the quality validation department, complying with previously established trainings for such activities. 13. Participate in employee training within the company to execute activities that help maintain, develop, and improve the data integrity program. **Reasonable Accommodation** Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link **Recruitment Fraud Notice** Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.