This list contains only the countries for which job offers have been published in the selected language (e.g., in the French version, only job offers written in French are displayed, and in the English version, only those in English).
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.
Job Responsibility:
Perform biological risk assessments
Document risk assessments in Baxter qualified systems
Generate protocols and reports for biocompatibility testing
Manage biocompatibility testing at external laboratories
Serve as a study monitor
Summarize biocompatibility testing in technical documents
Develop knowledge of ISO 10993 series standards
Develop knowledge of global compendia
Author BEP/BER for regulatory submissions
Work with GLP/GMP regulations
Requirements:
Perform biological risk assessments to determine biocompatibility testing required to demonstrate product safety
Document risk assessments in Baxter qualified systems such as Team Center Unified (TCU), Trackwise 8, Electronic Laboratory Notebook (ELN)
Generate protocols and reports for biocompatibility testing
Manage biocompatibility testing at external laboratories within budget and according to project landmarks
Serve as a study monitor for studies placed at external laboratories and review protocols and reports
Summarize biocompatibility testing in technical documents that may be used for regulatory filing
Develop knowledge and understanding of ISO 10993 series of standards for executing biological assays and toxicological risk assessments per ISO 10993-17 for medical devices
Develop knowledge of global compendia (EX: USP, EP, JP etc) supporting container closure systems registered as drugs
Author BEP/BER for regulatory submissions
Have a working knowledge and understanding of Good Laboratory Practice (GLP) / Good Manufacturing Practice (GMP) and related regulations and guidance