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 is where your creativity addresses challenges

Assure that equipment validation and manufacturing processes align with Corporate and Plant requirements. Work with engineering, manufacturing, maintenance and quality to assure equipment availability/ acceptance and production throughput. Provide data for inclusion in reports to regulatory agencies.

Your Team at Baxter

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.

What we offer from Day One

• Shift flexibility to trade shifts and leverage overtime opportunities
• Medical, Dental and Vision coverage
• 160 hours of Paid Time Off and Paid Holidays
• 401K match
• Employee Stock Purchase Program
• Paid Parental Leave
• Tuition Reimbursement

What you'll be doing

1. Validation

• Conduct qualification, requalification and evaluation studies
• Determine test requirements based on specification or protocol instructions
• Prepare and perform software testing
• Prepare and perform testing to high confidence levels
• Perform statistical studies/ data entry for Mini-tab and other statistical package
• Prepare report using Excel, Word and PowerPoint
• Perform studies per specification or protocol
• Evaluate results against specification, SOP or protocol requirements
• Identify out of specification/protocol conditions
• Issue exceptions reports
• Analyze data, materials and/or equipment to determine the cause of out of limits or exception conditions
• Prepare study package for management review and approval
• Review/approve change maintenance requests
• Perform protocol closure duties including labeling, assembling packages and routing
• Perform protocol retrieval, storage and audit functions to assure proper filing and documentation.
• Lead and/or direct protocol efforts and project validations including external protocols

2. Process Improvement

• Prepare monthly and quarterly trend reports
• Perform statistical studies/ data entry for Mini-tab and other statistical package
• Prepare and perform gauge repeatability and test method studies
• Perform capability and other acceptance functional testing
• Develop and apply physical testing on product as needed
• Review other certifications per applicable specifications

3. Cross Functional Duties:

• Perform audits and assessments to assure compliance with regulatory requirements
• Serve as SME
• Host internal and external meetings as required
• Perform training as needed
• Work with scheduling, production, quality and sterilization departments to schedule activities
• Talk to Corporate as needed
• Assist with risk based analysis and approve changes
• Serve as project lead when needed.
• Notify the supervisor and take appropriate action if any safety, quality or discrepancy issues occur
• Learn, understand and apply rigorous quality standards, Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP)
• Sustain a clean and safe work area using 6S principles including maintaining and securing provided tools

Work Environment

• Can include working in a Class I, Class II, Class III or Class IV Controlled Environment which may include the following dress/gowning requirements: safety glasses, ear plugs, hairnet, beard cover, isolation mask, gown, hood, boots or shoe covers and gloves. Additional PPE is required when cleaning
• There is constant or intermittent noise and vibration
• This position involves working around moving equipment, machinery and conveyors

What you'll bring

• Associate Degree with specialization in technical area, such as, metrology, instrumentation, electronics, mathematics, science or statistics OR 2 years of relevant experience.
• Basic Skills Training with demonstrated experience in the areas of project management, validation and testing.
• Experience in statistical and data analysis techniques.
• Must have basic English written and oral communication skills adequate to communicate with other team members
• Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings
• Must be able to perform advanced level mathematics
• Proven problem solving and analysis in the evaluation of test data and determination of data acceptability or validation of critical systems or equipment with responsibility for preparing test equipment and documentation, and identifying potential problems during validation studies.
• Process improvement experience in developing test plans, testing and completing technical reports. (preferred)
• Other Training /Experience (preferred)
• Proficient in: AS400, Trackwise, Maximo, Excel, word and Power Point

Physical Requirements

• Requires the ability stand/walk frequently throughout the shift.
• Ability to lift and carry up to 34 pounds
• Must be able to squat, reach above shoulder level, reach at or below shoulder level, kneel, twist and bend at the neck, twist and bend at the waist and balance

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 employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $40,000 - $55,000 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. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

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

Must be willing to work during plant downtime periods, including weekends and other shutdown periods.

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.