Principal Quality Sterilization Associate

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 position is a Sterilization and Microbiology subject matter expert. Responsible for results in terms of product quality and conformance to Sterilization and Microbiology regulations and Baxter quality policies.

What you'll be doing

• Drive compliance of programs and procedures for microbiological activities (Sterilization, Microbiology and Environmental Controls).

• Monitor industry regulatory standards and guidance (MMI/ ISO/ USP,          EP, PDA,). Perform standard assessments as required and interpret requirements into site level programs.

• Support EUMDR and FDA product submission activities. Provide technical documentation and responses to notified bodies.

• Develop risk-based approach methodologies to evaluate and continuously improve BET, bioburden, contamination control, and sterilization programs.

• Manage the activities of the sterility assurance with responsibility for results in terms of product quality, performance and safety. Implements the quality systems procedures and manages compliance in a section or department.

• Understands and assures conformance to regulations in the Microbiology laboratory, Sterilization (EO and Gamma).

• Interfaces with regulators during regulatory inspections.

• Responsible for the comprehensive strategy to maintain and improve clean room controls within the facility to minimize risk of contaminated product proceeding to sterilization department.

• May participate in or manage quality assessments of internal operations and suppliers to analyze compliance and assess risk.

• Interacts frequently with supervisors and functional peer group managers.

• Identifies and manages continuous improvement projects with the objective of achieving quality, reliability and cost improvements.

• Develops budget for the department and ensures adherence to the budget.

• Coach, mentor and train personnel on Sterilization and Microbiology best practices.

• Learn, understand and apply rigorous quality standards, Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP)

• Provide a technical resource for evaluating alternate sterilization technologies, contamination control, and process monitoring.

• Develop and refine strategies and methodologies for microbiological testing, cleaning validations.

• Collaborate with other Baxter sites to facilitate the harmonization of best practices and leveraging technologies across business units.

• Support Baxter QMS improvement initiatives related to Sterilization and Clean room processes including Risk Management update.

What you'll bring

• BS degree in Science, concentration in Biology or Microbiology, preferably. At least, 10 years of professional experience in Quality, Manufacturing, Engineering or related field which should include at least 5 years of supervisory experience.

• Strong knowledge and experience in several of the following areas of competency: terminal sterilization, aseptic processing, clean room and contamination control, environmental monitoring microbiological methods and cleaning validation.

• Experience with ISO class 8 clean room operational and qualification principles.

• Strong analytical and problem-solving skills.

• Demonstrated working knowledge of current industry standards related to sterilization and microbiology such as: 11135, 10993-7, 11137, 17655, 11737 , ST72, 14698, 14644 , 17141. Knowledge with biocompatibility 10993 series is a plus.

• Expert knowledge and understanding of Microbiology principles, theories, concepts and laboratory methodologies.

• Must demonstrate effective organizational skills and ability to manage multiple projects.

• Must have demonstrated experience analyzing and interpreting technical results and summarizing these results in technical reports.

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 $88,000 - $121,000 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. This position may also be eligible for discretionary bonuses. 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.

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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.

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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.

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