December 2, 2024
The Senior Project Engineer is responsible for leading and coordinating engineering activities across the full pharmaceutical development lifecycle, from preclinical through to commercial stages. This role plays a key part in managing CMC-related projects, including process validation, registration batch production, analytical method qualification, and the setup of commercial supply chains. The Senior Project Engineer ensures strict adherence to GMP, GxP, and ALCOA+ principles, while also supporting EHS objectives. Working closely with internal technical teams and external CDMOs, the role involves oversight of project scope, cost control, and risk analysis to ensure timely, compliant, and successful product development and market authorization.