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. 

Summary:

Be part of the large-scale capital projects team responsible for validating upgrades to site critical systems (Water for Injection, Process Control Air, Clean Rooms), manufacturing processes (Mixing Complex, Cleaning Processes), and similarly scoped projects.

Essential Duties & Responsibilities

• Ensure FDA regulations are met for system modifications/replacements, including the 2011 FDA Guidance for Process Validation, and Data Integrity CFR21 part 11.

• Works with engineering, maintenance, manufacturing, and other functional groups on the validation/qualification for various pieces of equipment, cleanrooms, and critical utilities

• Responsible for ensuring the quality of validation packages

• Evaluate new equipment or system changes based on risk

• Write, execute, and summarize test documentation of equipment and associated computer systems

• Provide support to resolve technical issues with systems under validation

• Perform engineering studies to determine proper equipment settings, control points, etc.

• Sustain a clean and safe work area using 6S principles

• Learn, understand, and apply company specifications, Standard Operating Procedures (SOPs), and Current Good Manufacturing Practices (cGMP)

Qualifications for this role

• Soft Skills: Critical thinker, engaged, solution-oriented

• Ability to work with diversified cross functional team across different plant locations

• Self-motivated and work well without direct supervision

• Ability to quickly learn and understand applications

• Familiarity with Rockwell platforms such as Wonderware, Allen-Bradley PLC, and Factory Talk View preferred

• IQ / OQ / PQ & Data Integrity (ALCOA) experience desired

• Must have strong English written and oral communication skills adequate to communicate in an audit environment

• Be able to work short-term flexible schedules as needed by the project to meet manufacturing deadlines

Education & Experience

• BS degree in Engineering or Science Discipline and at least 2 - 4 years related experience (in-house, co-op or acquired outside). Degree requirements may be waived in lieu of relevant validation or scientific background.

• Must be at least 18 years of age.

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.To that end, this position has a salary range of $60,000 to $132,000 and also includes an annual incentive bonus. The above range represents the expected salary range for this position.The actual salary may vary based upon several factors including, but not limited to, relevant skills/experience, time in the role, business line, and geographic/office location.

Other Duties as Assigned

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. Overtime is worked as required depending on project schedules.

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

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.