Staff Validation Engineer at Janssen Biologics Leiden, the Netherlands
Jennifer Spiegeler is Staff Validation Engineer at Janssen Biologics Leiden, the Netherlands. She has 20 years of experience in the Biologics Large Molecule field as she had former positions as QC compliance officer, GMP trainer, Bioprocessing specialist and QA specialist. Jennifer has a Bachelor Degree in Plant Biotechnology from the applied University of Rotterdam and is currently disserting her Master of Science degree at Technical University in Dublin in Pharmaceutical Validation Techniques.
She develops strategies for cycle development, qualification, validation and/or verification approaches for large molecule manufacturing (Covid 19 Vaccine and Monoclonal antibodies). She is a cleaning validation expert including development of risk based approaches, soiling assessments, maximum allowable carry-over calculation, development of cleaning cycles, cleaning verification and validation approaches. Next to that, she conducted risk assessments for product contact polymerics and is part of the development of a risk based approach for introducing new polymerics. Currently, she is project lead for scaling up manufacturing of a monoclonal antibody.