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Senior IT Specialist - Guadalajara

Req # JR - 068548 Location Guadalajara, Jalisco, México Job Category Information Technology Date posted 05/05/2022

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant 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

This position is responsible for leading and performing activities in support of the validation and compliance of a system or application. The Validation Lead will work with a large IT project team(s) to define Validation requirements and documentation to be used for Application/System qualification. Responsible for creating the documents required for the development and validation of the computerized system.

What you'll be doing

1.       Prepares documentation in Baxter’s document management system per policy and procedure to support the validation of enterprise systems and IT infrastructure.

2.       Responsible for creating, managing, and/or maintaining the documents required for the development and validation of the computerized system.

A.       Create and review all validation documents in the project.

i.      Authors Validation Plan, IQ Protocol/Report, OQ Protocol/Report, PQ Protocol/Report, Test Cases, Test Incidents, Trace Matrix, System Description, and Validation report.

ii.      Reviews User Requirements, Functional Specifications, Design Specifications, User Manuals, System Procedures.

iii.      Routes validation documents for electronic approval within the document management system or the electronic testing tool.

B.       Manages the computer system requirements within the electronic testing tool to align with the approved requirements.

3.       Oversight of protocol execution

A.       Manages and executes validation testing  plans – executes the overall protocol process, including test case creation/approval, test case tracing to the system requirements,  test case execution reviews, test incident management, and status reporting

B.       Maintains the trace of the system requirements to the test cases within the testing tool

C.       Coaches testers on good testing and documentation practices

4.       Prepares documentation within a validation package per policy and procedure to support the     validation of an application/system.

What you'll bring
1.       Experience in Software Development Life Cycle (SDLC) or Software Validation within the Medical Device or Pharmaceutical industry.

2.       Strong knowledge of project development/implementation processes.

3.       Ability to make good judgments and quick decisions.

4.       Solid oral and written communication skills and teamwork skills.

5.       Proficient in MS Word

6.       Experience in HP ALM a plus

7.       5 years of experience in the Medical device or Pharmaceutical industry

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to [email protected] and let us know the nature of your request along with your contact information.

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