Nicky Young

Senior Director, Sterility Assurance at Teknova

Speaker

Nicky Young joined Teknova’s Quality organization as the Senior Director of Sterility Assurance in 2022, where she has been instrumental in the building and validation of their new GMP facility. Nicky has been heavily focused on the certification of the cleanroom in accordance with ISO 14644 standards, including EMPQ, smoke studies and disinfectant validation, the microbial contamination control strategy, as well as developing the media fill, aseptic training, environmental monitoring, trending, and cleaning and disinfection strategies and programs.

With more than 28 years of experience in sterility assurance and aseptic pharmaceutical manufacturing, Nicky has worked across at numerous pharmaceutical companies, ranging from CSL Behring and Baxter International to Patheon (Thermo Fisher) and GE Healthcare. She has also worked at large CDMOs where she was responsible for 15 manufacturing lines across two different sites, averaging 15 audits a week, and has overseen the quality of the manufacture of a variety of products, ranging from vaccines to sterile eyedrops to injectables and wound dressings.

As the Global Head of Sterility Assurance at Baxter International, she was responsible for 23 sites, including inspections from the FDA, MHRA, and TGA, among other international regulatory institutions.