Sterility Assurance Scientist

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.

Sterility Assurance Scientist

Are you ready to make a significant impact in the field of Clinical Nutrition? At Baxter, we offer more than just a job—we provide an opportunity to work on groundbreaking and unique projects that truly make a difference.

As part of our highly skilled R&D team, you will collaborate closely with the Sterility Assurance Manager to provide leadership on multi-disciplinary teams. Your role will involve supporting innovative design solutions and developing strategies to ensure success. You will contribute to the technical feasibility analysis of complex research and design concepts, as well as evaluate product requirements.

What you'll do :

• Lead Sterility Assurance Initiatives: Manage product development projects as the Sterility Assurance Focal Point, participating in cross-functional product development teams for sterilization projects.

• Technical Recommendations and Analysis: Make sound technical recommendations regarding routine projects, providing analysis and redesign of key experimental procedures. Independently select techniques and procedures to solve problems within your area of responsibility.

• Validation and Compliance Support: Write rationale statements for product testing and sterilization projects, and provide validation support for Baxter manufacturing facilities. Write, execute, and review validation and qualification protocols and reports.

• Experimental Design and Execution: Plan, design, and execute microbiological experiments, while evaluating and interpreting technical data and test results. Contribute to technical feasibility analysis of complex research and design concepts.

• Regulatory Knowledge and Compliance: Maintain knowledge of relevant Quality System Regulations and safety requirements, while building expertise in other regulatory requirements related to R&D. Ensure compliance in all research, data collection, and reporting activities.

• Budget and Schedule Monitoring: Monitor budgets and activity schedules of limited scope, ensuring projects stay on track and within budget.

• Expert Insights and GxP Knowledge: Provide expert insights into GxP regulations to facilitate efficient product registration. Actively participate in the generation, review, adoption, and interpretation of relevant regulations.

• Problem Solving and Analysis: Demonstrate the ability to apply technical theories and principles to non-routine tasks, analyzing and determining the best solutions to experimental design or research problems with minimal assistance. Accurately assess results for validity and conformance to specifications.

What You'll Bring:

• Proactive and Collaborative Approach: Enthusiastically embraces professional growth opportunities and demonstrates a proactive attitude. Agile and able to jump into challenges, working collaboratively across the business to find solutions.

• Accountability and Adaptability: Takes accountability for own behavior and adjusts appropriately. Steps outside of the comfort zone to drive process improvements through critical thinking.

• Hands-On Participation: Contributes through demonstrated hands-on participation within teams. Responsible and dedicated.

• Education and Scientific Background: Master of Sciences or Ph.D. in Life Sciences, with a focus on Microbiology, Biochemistry, Molecular Biology, or Biology.

• Experience/Expertise: 2-4 years of experience in QC/QA microbiology, with a background in sterility assurance in the pharmaceutical or medical device industry, including moist heat and irradiation sterilization technology.

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.

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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