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Sr. Specialist, IT Validation

Req # JR - 150043 Location Guadalajara, Jalisco, México Job Category Information Technology Date posted 11/01/2024
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Overview

This is where we value your strategic mindset, technical expertise and passion for innovation. If you are someone who has the ability to transform strategies into actionable plans while also demonstrating empathy and a willingness to assist others, this might be the right opportunity for you. Your contributions will make a significant impact on Baxter's mission to save and sustain lives.

  • Paid Time Off

  • Employee Heath & Well-Being Benefits

  • Continuing Education/ Professional Development

  • Support for Parents

  • Employee Assistance Program

Success Profile

What makes a successful Information Technology team member at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit.

  • Strategic Business Partner
  • Communicator
  • Curious
  • Results driven
  • Collaborative
  • Problem Solver

Sr. Specialist, IT Validation

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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 WhereWe 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.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter 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.

150043
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Address

Explore this location #5153, 5th. Floor
Boulevard Puerta de Hierro
45116 Zapopan, JAL
Mexico
Explore This Location

Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Meet Anchal Tayal, Principal Software Engineer, India

“I am proud to be associated with a company whose mission is to Save and Sustain lives. As a Principal Engineer, my key responsibility is to design and implement the new product features in the most efficient, effective, and maintainable way. These products are designed to empower our patients worldwide. It has been an exciting journey so far full of learnings and a sense of satisfaction in what we do and how it impacts lives.”

Meet Jorge Ramirez, Senior Specialist - Mexico

“Technical skills are really important, but in my case, Baxter helped me in developing soft skills like leadership, work ethic, problem-solving, adaptability, and communication. I’ve learned this by following the example of my manager and some other valuable people. Baxter was the first company that offered me a career plan since the beginning, that was a game changer for me.”

Meet Malgorzata Grzesik, Senior Project Manager, USA

“I feel that everything that I know at work, I learned it from others. We have amazing people from all over the world with different backgrounds, whom I get to work with and learn from every day. I am part of an organization where developing new skills and growing professionally are welcomed and embraced. I have been given many opportunities to grow and take on new challenges. I am also excited and ready for the new ones to come along. With the support of our IT leaders and amazing teammates, we do great things.”

Meet Reagan, Senior Research Scientist in the United States

“For me, the best thing about working at Baxter is being able to do work that’s important to people—especially patients—outside of Baxter's walls. Inside our walls, I get to work with a fantastic team, and we know we're making a difference.”

Meet Karthik, Director of Renal Care R&D - Digital Health & Co-President of the Asian Leadership Network Business Resource Group, United States

“I’m excited about my role because I believe that digital initiatives can make a tremendous impact on lives by allowing people to access the same therapies and have similar care — whether in a hospital, a healthcare clinic, or the patient’s home — anywhere in the world.”

Meet Amitha, Research Associate in India

“Coming from a non-healthcare academic background, my current role has offered ample opportunities to learn a lot of new things. Leaders at Baxter are motivating, help us grow and provide a collaborative environment. The role gives me opportunities to have technical discussions with peers and subject matter experts globally, to learn interacting with customers, and manage project deadlines and deliverables. I am excited about shaping my career here at Baxter.”

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