Validation Specialist II

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

Responsible for assisting in Quality Critical System and Facility Design and Maintenance, in addition to providing technical support and service to these areas, the incumbent may also perform the following functions: supervising, requisitioning, defining, initiating, specifying, documenting, and training. Works independently performing standard commissioning and qualification work requiring application of cGMP practices, procedures, and criteria.

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

• 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

• Act independently with minimal direction to conduct approved projects. Possess the technical knowledge required to complete assigned responsibilities
• Able to complete work you're doing in a variety of subject areas, including change control, protocols, analytical equipment qualification, method validation, cleaning validation, and process validation.
• Ability to work multi-functionally to establish working unions with other department representatives.
• Responsible for scheduling tasks and meeting plant requirements for area in which you are assigned.
• Investigate and analyze customer service problems and process improvement suggestions. Recommend process improvements
• Be able to defend and connect with external auditors.
• Develops and or lead in the development of solutions to problems specific to assigned projects
• Able to lead or assist continuous improvement projects.
• Works with manufacturing and other functional groups on manufacturing regulatory compliance issues.
• Writes, implements, and reports on validation activities. Coordinates validation issues specific to the product/process design, validation, and ongoing monitoring. Writes and/or implements qualification protocols for various analytical equipment, methods, cleaning, and manufacturing processes.
• Designs and performs routine testing, project experiments, analysis of data and reports results.
• Performs studies on new processes to optimize critical process parameters, etc. including data gathering during test batches.
• Initiates new or revisions of protocols/operating instructions specific to the project.
• Performs work assignments within production department that include training, technical support and/or process trouble shooting support.
• Interprets, implements, and recommends modifications to operating policies where appropriate.

What you'll bring

• Bachelor’s Degree in science, engineering, or related field and 3 – 6 years proven experience in commissioning, qualification, and validation from a cGMP environment (in-house, co-op or acquired outside).
• Ability to discuss normally encountered technical or project management issues, both verbally and in written form.
• Ability to tackle routine analytical or process related problems.
• Ability to perform statistical analysis of data collected throughout various projects.
• Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words, process flow diagrams, and related drawings.
• Must have good English written and oral communication skills.

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 $80,000 - $110,000 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 crafted 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.

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time

US Benefits at Baxter (except for Puerto Rico)

This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter

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.

Know Your Rights: Workplace Discrimination is Illegal

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.