Research Associate (H/F)

The Research Associate I supports Sterility Assurance activities for new product development and existing product improvement projects. The role focuses on terminal sterilization, microbiological validation, technical risk assessment, and preparation of controlled study documentation. • Author and issue Sterility Assurance study protocols, amendments, reports, and supporting documentation. • Support sterilization cycle development, fractional exposure validation, heat-distribution studies, and process qualification. • Coordinate study preparation with manufacturing sites, laboratories, Quality, Engineering, and cross-functional project teams. • Provide on-site support at manufacturing facilities during study execution, including verification of study readiness, coordination of activities, collection of documentation, and resolution of operational issues. • Review sterilization cycle records, process parameters, temperature and pressure data, datalogger outputs, probe configurations, biological indicator results, and production records. • Coordinate and execute biological indicator testing. • Coordinate microbiological activities such as bioburden, bacterial endotoxin, microbial growth, and other validation or verification studies. • Coordinate testing with internal and external laboratories, including sample shipment, traceability, testing requirements, results, and reports. • Assess product, process, packaging, equipment, raw material, and manufacturing changes for potential Sterility Assurance impact. • Prepare Sterility Assurance rationales defining whether validation studies are required or whether existing technical evidence may be leveraged. • Track assigned activities, documentation, risks, dependencies, timelines, and follow-up actions. • Organize and analyze study data and prepare scientifically justified conclusions and final reports. • Ensure that all work complies with applicable Baxter procedures, Quality requirements, data-integrity expectations, and relevant regulatory guidance.

• Bachelor’s or Master’s degree in microbiology, biotechnology, pharmaceutical sciences, biomedical sciences, chemical or biochemical engineering, life sciences, or a related scientific discipline. • Early-career profile with a strong interest in sterile products, microbiology, sterilization, validation, or pharmaceutical manufacturing. • Ability to understand scientific information and translate it into clear protocols, reports, and technical conclusions. • Strong organizational skills and attention to detail, particularly when managing study documentation and technical data. • Ability to coordinate activities across manufacturing, laboratory, Quality, and project teams. • Comfortable working in both office and manufacturing environments. • Willing and able to travel regularly to manufacturing sites and laboratories. • Valid driving license required. • Good spoken and written English required. • Good spoken French required for effective coordination with local manufacturing and laboratory teams. • Proficiency in Microsoft Word, Excel, and PowerPoint. • Proactive, collaborative, and able to manage changing priorities while meeting agreed deadlines.

Baxter is more than a company. It is a community of committed professionals. Every year, our products reach more than 60 million patients worldwide. Baxter has a diverse group of employees in more than 100 countries who share a passion for saving and sustaining lives. Whether you join us for few years or your entire career, we are united to advancing modern healthcare. Fostering collaborative innovation, continuous learning and diversity are part of our DNA. If you eager to grow in a stimulating, caring environment and look for a daily basis purpose, we are the place to be! During your assignment with us, you will benefit from the presence of a large community of well-established VIEs, as well as numerous activities and benefits.