Principal Validation Engineer

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. 

About Baxter’s Cleveland, MS Facility:

Cleveland’s technology and automation are innovative.  It is the U.S. source for plastic pour bottles, glass IV, and various reconstitution devices.   This facility has several major product lines with a diverse array of automated manufacturing technologies including bottle solution filling, injection molding, and device assembly.

Our Cleveland plant has been an integral part of Baxter for over 70 years.  The work is challenging and rewarding, as Baxter offers competitive compensation and benefits.  Baxter encourages and values every employee and believes that each person can contribute to advancing healthcare for patients; work to be proud of.


Your Team:

Within Quality, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product, it is sure to touch a portion of our global operation.

The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always.

The Quality function values both working together as a team and independently. We draw energy from working in a plant or an office where there are opportunities to collaborate. As the company evolves, so does the way our team approaches work as it strives to create top-of-the-line products.

What you'll be doing:

• Must perform equipment qualification, test method and process validation activities, process capability and process control studies for assigned areas.

• Must plan and implement software validation activities in manufacturing and support areas.

• Must drive quality/manufacturing projects applying Lean, problem solving, process control, and project management tools to achieve and sustain operational excellence.

• Must support Manufacturing, Engineering, and Quality Management departments with the development and implementation of new processes/technologies.

• Must assist in the identification and development of process improvement projects including automation and computerization.

• Must ensure computer systems and applications are aligned with regulatory quality standards through validation activities.  May serve as SME for Computerized System Validation processes.

• Responsible for ensuring FDA regulations are met for system upgrades/replacements.

• Responsible for audits, creation, and implementation of Specifications/SOPs.

• Responsible for ensuring the quality of facility systems (validation):

• Writing and implementing protocols and test cases for validations.

• Coordinating testing and documentation of projects.

• Documenting/performing changes to applications.

• Assisting/leading training for systems.

• Diversified knowledge of applied Statistical Analysis techniques, procedures, and criteria to carry out measurements, process, and product capability studies for the development of new or refined equipment, materials, processes, instruments, and products.

• Must perform failure investigations and supervise follow-up corrective actions.

• Ability to function effectively as a member of a team.

• Ability to plan and prioritize different projects to ensure completion within the target dates.

• Ability to communicate effectively in written and verbal form.

• Must have knowledge of both plant and department environmental health and safety regulations and follow said regulations accordingly.

• Must perform all other duties and responsibilities as determined by supervision/management.

What you'll bring:

• BS degree required. (Preference in Engineering, Computer Science or other core Science Field)

• 3 years or more minimum related experience (in house, or acquired outside).

• Knowledge of applications such as Wonderware, Allen-Bradley PLC/HMI, Access, Microsoft Project preferred.

• Basic knowledge of manufacturing processes and the ability to quickly learn and understand processes/applications.

• ASQ Certification (CQE or CSQE) or equivalent desired.

• Leadership skills.

• Ability to work independently or with a diversified multi-functional team across different locations.

• Ability to mentor new Engineers to the Company.

• Logical thought process.

• Self-motivated and works well without direct supervision.

• Quality Assurance or Pharmaceutical industry experience desired.

• Ability to lift to 10 pounds, to sit, stand and/or walk for long periods of time.

• Ability to reach above the shoulder, to bend/stoop.
  

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all our employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $104,000 - $143,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors.

#IND-USOPS

The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.

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 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

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