Specialist, Engineering

Role: The PSL Specialist at the Durham vaccine manufacturing site is responsible for managing technical projects supporting vaccine process development, investigations, and continuous improvement. Responsibilities include executing laboratory studies, analyzing data, authoring technical documentation within cGMP standards, supporting process transfers, and troubleshooting laboratory and manufacturing issues. The role requires active collaboration with Manufacturing, Quality, and Technical Operations teams, supporting cell culture processes, laboratory analytics, and process monitoring. Qualifications: Bachelor's in Engineering or Science with at least 2 years of relevant experience, or advanced degrees with academic support in vaccine or biologics processing, cGMP documentation, and analytical techniques. Preferred skills include experience with aseptic cGMP environments, experimental design (DOE/OFAT), authoring regulatory documents, and familiarity with analytical assays and equipment (e.g., UPLC, bioassays). The position involves occasional off-shift and weekend work, with a travel requirement of approximately 10%. High-Value: Focus on vaccine manufacturing support, process monitoring, investigations, and technical transfer in a cGMP setting, contributing to the development and support of Durham-based vaccine products.