Around the world, our employees are united by our mission to save and sustain lives. Together, we create a culture that encourages colleagues to pursue rewarding careers -- where everyone has the opportunity to do meaningful work as a part of a team they respect, in an environment that values each person’s contributions. We’re happy you’re interested in continuing your career journey with Baxter.

Position Overview:

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’s intended use.  The Software Validation Engineer will work with a Manufacturing, Engineering and IT team(s) to validate Systems that are compliant to applicable regulations (21 CFR Part 11, GxP Regulations) and Baxter Quality Management System.

Essential Duties and Responsibilities:

• Prepares documentation in Baxter’s document management system per policy and procedure to support the validation of Systems supporting Manufacturing Plant. Identify and escalate, as necessary project risks and issues to the Project Manager and/or Site Leadership. Responsible for creating, managing, and/or maintaining the documents required for the development and validation of the computerized system.Create/Review validation documents in the project following Software Development Life Cycle (SDLC).
• Working with Business partners, create/reviews User Requirements, Functional Specifications, Design Specifications and Configuration Specifications.
• Authors Validation Plan, IQ Protocol/Report, OQ Protocol/Report, PQ Protocol/Report, Test Cases, Risk Management Report, Test Incidents, Trace Matrix, System Description, and Validation Report.
• Routes validation documents for electronic approval within the document management system or the electronic testing tool.
• Protocol/Test Execution
• Outlines testing based on the Risk Management strategy.
• 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 incident management, and status reporting.
• Maintains trace of the system requirements to the test cases per Baxter QMS.
• System Support and Maintenance
• Drives System Inventory Management, Change Control, Problem Investigation, and Periodic Review activities.
• Creates/Reviews System Management Procedures and Manuals to ensure Systems are maintained in validated state.
• Provides internal/external audit support for Computerized Systems.

Desired skills / Certifications / Training:

• Minimum BA / BS or relevant work experience in information systems, engineering, science 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 project development/implementation processes.
• Excellent analytical and judgment capabilities and communication skills, and the ability to work with Cross-Functional Teams. Self-motivated, detail oriented, takes initiative and ability to work independently without close supervision.
• Proficient in use of Microsoft Office Applications Experience in HP ALM a plus to manage requirement and testing

Education:

• BS Degree in Engineering, Science or related field
• 3 years of experience in the Medical device or Pharmaceutical industry

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
                                                                                                                                                               
EEO is the Law 
EEO is the law - Poster Supplement

Pay Transparency Policy

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 Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.