Sr. Specialist, IT Validation

Vantive: A New Company Built on Our Legacy

Since last year, Baxter has been on a journey to separate our Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. 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 are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support.

*Completion of the proposed sale of Vantive to funds managed by the Carlyle Group is subject to receipt of customary regulatory approvals and satisfaction of other closing conditions.

This is Where We Save and Sustain Lives

About Us: Baxter's Mission:

At Baxter, we are deeply connected by our mission. Regardless of your role at Baxter, your work has a positive impact on people around the world. You'll experience a sense of purpose throughout the organization as we know our work improves outcomes for millions of patients.

Baxter products and therapies are found in nearly every hospital around the world, in clinics and at home. For more than 85 years, we have pioneered important medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives, where your purpose accelerates our mission

Your 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.
• Thorough knowledge of GxP regulations (e.g. 21 CFR Part 11, etc.), Standards, and Industry Best Practices.
• Experience in Software Development Life Cycle (SDLC) or Software Validation within the Medical Device or Pharmaceutical industry.
• Strong knowledge of software development/implementation processes.
• Experience working with Application Lifecycle Management tool (ALM) to manage requirement traceability, and testing and testing defects

Competencies:

• Communication.
• Focus on clientele.
• Self-management
• Critical Thinking and Problem Solving.
• Management of ambiguity.

Reasonable Accommodations

Baxter 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.

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