R&DSterilityAssurance-ProjectLead

**This is where** your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride. ## **Shape the Safety of Life‑Saving Therapies** At Baxter, our mission to save and sustain lives is driven by scientific rigor and regulatory excellence. As an **R &D Sterility Assurance Project Lead**, you act as a technical focal point, defining and executing robust sterility assurance strategies to ensure product safety, quality, and compliance. You lead sterility assurance activities across complex R&D programs, applying advanced engineering and regulatory principles to solve non‑routine challenges and support multidisciplinary teams that develop, commercialize and support products on the market. ## **What You Will Do** **Sterility Assurance Leadership** * Act as the **Sterility Assurance Project Lead / Focal Point** for R&D programs. * Define and execute sterility assurance strategies, including **test method** **validation plans, rationale statements, and sterilization parameters**. * Provide interpretation and guidance on **GxP and global sterility regulations**. * Support **regulatory submissions** related to sterility assurance. **Project & Technical Ownership** * Lead sterility assurance activities with a high degree of autonomy across projects of broad scope. * Contribute to **project planni