Quality Assurance Engineer - TPI

Quality Assurance Engineer - TPI

TerraPower Isotopes (TPI) is seeking an experienced Quality Assurance Engineer to support the design, construction, and commissioning of a state-of-the-art cGMP radiopharmaceutical manufacturing facility. This role provides critical quality support across all phases of the project and will operate under stringent FDA and NRC regulations. The Quality Engineer will report to the Senior Manager Quality Assurance and work closely with a multidisciplinary team including engineering, R&D, procurement, and project management, and ensure the project is delivered safely, on schedule, and within budget while all quality/compliance requirements are met. This facility will require development of the Quality Management Systems and quality processes to support all aspects of the project from design, commissioning through operational readiness, ensuring compliance with cGMP and radiation safety standards throughout the project lifecycle.

Responsibilities:

• Contribute to the development and implementation of the Quality Program for TPI. Support implementation of Quality Management System. Author, revise, and manage approval of site policies and procedures related to Quality.
• Ensure data integrity compliance across quality systems, including adherence to ALCOA+ principles and 21 CFR Part 11 requirements.
• Initiate and manage risk-management activities, contributing to risk-based decision making.
• Balance quality requirements with safety, such as radiation safety, in all quality initiatives.
• Provide comprehensive, quality-related training to colleagues involved in the TPI enterprise.
• Develop processes for validation/qualification of equipment, facility, and/or manufacturing processes.
• Manage and assess change control proposals to ensure changes are implemented in a compliant and controlled manner.