TITLE: Quality Assurance Engineer - TPI
LOCATION: Everett, WA
The TerraPower Isotopes® (TPI™) division has been established to pursue medical isotopes development-advancing nuclear science for significant human health benefits. We seek to support revolutionary radiotherapies for treatments of various cancers through the supply of radioisotopes. TerraPower currently has unique access to a supply of thorium for the long-term production of actinium-225 in the growing alpha therapy market and intends to expand into other nuclear related medical treatments.
The TerraPower Isotopes (TPI) program is an integral part of the Washington State based TerraPower team, a company working to raise living standards globally. In 2006, the company originated with Bill Gates and a group of like-minded visionaries who evaluated the fundamental challenges to raising living standards around the world. TerraPower’s mission is to be a world leader in new nuclear technologies, while developing innovators and future leaders in the nuclear field.
TerraPower is seeking to hire highly motivated and forward-thinking professionals who are interested in focusing on advanced radiopharmaceutical applications and influencing change within nuclear medicine. TerraPower is an Equal Opportunity Employer. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected veteran status, or any other characteristic protected by federal, state, or local law. In addition, as a federal contractor, TerraPower has instituted an Affirmative Action Plan (AAP) to proactively recruit, hire, and promote women, minorities, disabled persons and veterans.
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.

Key Qualifications and Skills:

• Bachelor’s degree in a life sciences discipline, engineering, or a related field (or equivalent qualification through experience).
• 6+ years’ industry experience in a regulated production environment (e.g., ISO 9001, cGMP pharmaceutical or radiopharmaceutical industries), including 3+ years of prior experience in a Quality Assurance role.
• Certification in a pharmaceutical Quality-related discipline, Lean Six Sigma or project management training/certification is a plus.
• Demonstrated experience working within Quality Systems and providing collaborative customer support in Quality Assurance, Quality Control, or Operations. Strong working knowledge of quality principles, with proven success in managing complex projects and a wide range of responsibilities.
• Experience working within a quality program compliant to FDA/cGMP requirements Title 21 CFR 210/211 and ICH Guidance. Experience in a production radiopharmaceutical facility is preferred.
• Strong attention to detail, with the ability to interpret federal regulations, guidance and standards. Incorporate relevant requirements into TPI documentation and provide guidance to personnel regarding compliance.
• Must demonstrate flexibility in adjusting to changing priorities and schedules in a dynamic environment. Occasional evening or weekend work might be required to support production operations or project deliverables.
• Strong interpersonal skills with demonstrated ability to lead cross-functional teams and drive accountability.
• Excellent written and verbal communication skills, including technical writing proficiency and executive-level reporting abilities.
• The successful candidate will possess a high degree of trust and integrity, communicate openly, and display respect while fostering teamwork

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.
• Provide QA oversight during technology transfer and scale-up activities in support of production expansion initiatives.
• Manage a supplier qualification program, including monitoring supplier performance and ensuring compliance.
• Participate in Quality System audits (supplier, customer, and internal audits). Collaborate to resolve audit findings and track follow-up actions to closure.
• Support regulatory inspection readiness activities and represent QA during agency inspections or external audits.
• Lead project workstream assigned to Quality. Assemble, analyze, and report QA data metrics to detect trends and identify areas for improvement.
• Crosstrain to provide Quality support for routine production activities at the Everett laboratory (e.g., approval of deviations, change controls and CAPA, document review/approval and product disposition).
• Perform other general Quality duties associated with the position in alignment with the phase of the project.

Key Qualifications and Skills:

• Bachelor’s degree in a life sciences discipline, engineering, or a related field (or equivalent qualification through experience).
• 6+ years’ industry experience in a regulated production environment (e.g., ISO 9001, cGMP pharmaceutical or radiopharmaceutical industries), including 3+ years of prior experience in a Quality Assurance role.
• Certification in a pharmaceutical Quality-related discipline, Lean Six Sigma or project management training/certification is a plus.
• Demonstrated experience working within Quality Systems and providing collaborative customer support in Quality Assurance, Quality Control, or Operations. Strong working knowledge of quality principles, with proven success in managing complex projects and a wide range of responsibilities.
• Experience working within a quality program compliant to FDA/cGMP requirements Title 21 CFR 210/211 and ICH Guidance. Experience in a production radiopharmaceutical facility is preferred.
• Strong attention to detail, with the ability to interpret federal regulations, guidance and standards. Incorporate relevant requirements into TPI documentation and provide guidance to personnel regarding compliance.
• Must demonstrate flexibility in adjusting to changing priorities and schedules in a dynamic environment. Occasional evening or weekend work might be required to support production operations or project deliverables.
• Strong interpersonal skills with demonstrated ability to lead cross-functional teams and drive accountability.
• Excellent written and verbal communication skills, including technical writing proficiency and executive-level reporting abilities.
• The successful candidate will possess a high degree of trust and integrity, communicate openly, and display respect while fostering teamwork.

Job Functions are physical actions and/or working conditions associated with the position. These functions may also constitute essential functions for the job which the employee must be able to fulfill, with or without accommodation. Information provided below is to help describe the job so that the applicant has a reasonable understanding of the job duties/expectations. An applicant’s ability to perform and/or tolerate these actions and conditions will be discussed and workplace accommodations may be made on a case-by-case basis following an individualized assessment of the applicant and other considerations, including but not limited to any governing safety standards.

• Motor Abilities: Sitting and standing for extended periods, bending/stooping, grasping/gripping, fine motor control (hands).
• Physical exertion and/or requirements: Minimal, with ability to safely lift up to 25 pounds.
• Repetitive work: Prolonged.
• Special Senses: Visual and audio focused work and ability to perform role in personal protective equipment.
• Work Conditions: Stairs, typing/keyboard, standard and/or sitting working environment of >8 hrs./day.
• Travel required 10-20