Senior Specialist, Vaccines Technology

Role: Senior Specialist in Vaccines Technology supporting formulation, filling, inspection, and packaging operations within a Points of Dispensing (POD) vaccine manufacturing facility. Main objectives include startup, commissioning, tech transfer, validation, licensure, and ongoing technical support for vaccine manufacturing processes. Responsibilities: develop robust processes ensuring consistent quality and supply; resolve technical issues; manage Manufacturing Execution System (MES) batch records; act as subject matter expert during regulatory inspections; generate and document validation data; execute change management; investigate and implement CAPAs; support project deliverables and continuous improvement initiatives; collaborate with Operations, Quality, and other teams. Qualifications: Bachelor's degree in Engineering or Science; minimum of 4 years' experience in pharmaceutical packaging; at least 2 years in a cGMP biopharmaceutical/vaccine environment with direct equipment validation involvement. Preferred: experience with aseptic filling, CIP/SIP systems, serialization, and regulatory inspections, especially FDA; knowledge of SAP/MES; skills in data analysis and process control. High-value: focus on vaccine manufacturing, process validation, tech transfer, and regulatory readiness in a cGMP setting. Work setup: hybrid in North Carolina, with 10% travel expected.