Sr. Engineer 1, Process Validation

Job description

Position Overview The Senior Engineer or Scientist of Process Validation 1 ensures that manufacturing processes meet the validation and regulatory requirements to ensure the process is robust and reproducible under normal operating conditions. This role involves designing, executing, and documenting process validation protocols for equipment, systems, and manufacturing processes. Additionally, this role works closely with cross-functional teams to ensure that processes are consistently producing high-quality products in a safe and efficient manner. Company Overview: FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We’re looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we’re proud to cultivate a culture that will fuel your purpose, energy, and drive—what we call Genki. Ready to shape the future of medicine? Let’s transform hea...