Sr. Specialist, It Validation | (Z-111)

Sr. Specialist, It Validation | (Z-111)

.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 Where We Save and Sustain LivesYour role at Baxter:Main objective of the position:This position is accountable for leading and performing activities in support of the validation and compliance of a computerized system to ensure system meets its intended use.
The Validation Lead will work with key stakeholders in IT and business units to ensure a computerized system is compliant to applicable regulations (21 CFR Part 11, GxP Regulations) and our organization's Quality Management System requirements.Your team:At Baxter, our team values speed, agility, courage, and collaboration.
We offer autonomy and a flexible work environment.




Come join our team!What you'll be doing:Prepares computer validation documents and deliverables to support the validation of computerized System supporting a manufacturing plant.Identify and escalate, as necessary project risks and issues to the project manager or appropriate leadership for manufacturing sites.Responsible for creating, managing, and/or maintaining the documents required for the development and validation of the computerized system.Coordinates the preparation and routes validation documents in the project following Software Development Life Cycle (SDLC).Authors Validation Plan, Test Cases, Risk Management Report, Test defects, Trace Matrix, System Description,



and Validation Report.Routes validation documents for electronic approval within the document management system or the electronic testing tool.Manages and executes validation testing plans and test cases – executes the overall protocol process, including test case creation/approval/execution/reviews, test case tracing to the system requirements, test defect management, and status reporting.What you'll bring:Minimum B.A.
or B.S.
in Information Systems, Business, Engineering, or Life Sciences.Minimum 3 years of experience in the medical device or pharmaceutical industry relevant work experience in information systems, engineering, life sciences or business

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