Sr. Eng. Validation

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.**Primary Purpose of Position**:Responsible for activities to develop and execute validation and qualification protocols to comply with Vantiver's internal policies and international standards, as well as strengthen continuous improvement in manufacturing and production processes for critical plant services.**Key Activities and Responsibilities**:This is a Quality Assurance and Regulatory Affairs Engineering position, with activities to promote continued compliance with ISO13485 and FDA Law (all) but with special attention to 21CFR 820.1, 5, 20, 22,30(h) 30(i), 40, 100, 120, 180, 181 and 186, and the analogs of 13485, (MDSAP) for medical device manufacturing.The position has the responsibility to have a detailed System to coordinate and execute activities in TCU and TW, as well as to support Management in the coordination of the Validation Program, CAPA Actions, (Corrective and Preventive), Verification Actions, according to the QMS and regulatory compliance of the Systems area, in its applicable elements and the Systems involved in the realization of the product, as well as the correct traceability, Change controls, Perform with a high sense of Discipline, Commitment and Responsibility, in a good working environment.1. Serves as a backup for the position of Validation Supervisor.2. Supports in the supervision of his group of engineers to achieve department objectives and ensure compliance in the execution of Validations.3. Ensures that sampling plans are correctly applied in validations.4. Responsible for the review of protocols against procedures.5. Responsible for the review and approval of interim reports and opinion in validations.6. Monitor compliance with FDA regulatory requirements of countries to which the product is exported, international standards (ISO 9001/ISO 13485) and corporate requirements with special attention to 21CFR 820.22, 30, 65, 70, 75, 90, 100, 130, 184, and 198, MDSAP.7. Statistical analysis of process variation, process/product control, risk analysis of plant product families, implementation of improvement actions resulting from analysis of internal and external product experience data.8. Ensure compliance to applicable regulations to maintain validation status.9. Perform qualification and validation process activities.10. Qualify critical equipment and systems used in manufacturing processes.11. To comply with the Validation Master Plan in force.12. Review and approve validation protocols and reports.13. Collect information attached to the validation protocols.14. Maintains the software validation program.15. Develop and maintain updated procedures applicable to qualification and validation processes in accordance with corporate standards and national and international legislation.16. Provide compliance to GAMP 5, Annex 11 EC, CFR 21 part 11 and international standards focused on computer system validation and data integrity enforcement.17. Report metrics in charge of your area in Validations.18. Support the Internal Audits program.19. Interact directly with your immediate boss, in a Loyal, Honest manner, maintaining a high sense of involvement with transparency and communication in all day to day activities.20. Maintaining a good working environment. Must prevent possible impact on the non-compliance of local and global metrics, where the Validations and Regulatory Affairs area is involved.21. Interacts frequently with all levels of Supervision and Management Staff, as well as key personnel, providing clear and accurate information that could impact the manufacturing of the product realization.22. Ensure qualification and operation of controlled areas within applicable environmental specifications.24. Directly responsible for ensuring that new entrants must complete their BaxU training prior to performing departmental activities involving receipt inspection activities such as component release, segregating material to MRB.25. NCR Investigations, CAPA assigned and/or