Principal Engineer, Technical Operations

Job description

Job Summary The Principal Technical Operations Engineer (Radiopharmaceuticals) is responsible for leading and managing the development, implementation, and continuous improvement of processes within radiopharmaceutical operations. This role is critical for ensuring product quality, regulatory compliance, and operational efficiency. The Principal Technical Operations Engineer will serve as a Subject Matter Expert (SME) for all process-related questions, actively manage Non-Conformance Reports (NCRs), Corrective and Preventive Actions (CAPAs), and Change Controls , and directly assist operations to achieve excellence in radiopharmaceutical manufacturing and support. The Principle Engineer will also create new processes such as Master Batch Records for clients as they onboard to the CMC facility. Responsibilities: Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects related to radiopharmaceutical processes. Leads the creation, optimization, and documentation of new and existing operational processes for radiopharmaceuticals, ensuring alignment with ISO 13485 and 21 CFR 820 Quality System R...