Quality Validation Specialist/Senior Specialist

TerraPower.•Everett, WA

8d•Onsite

About The Position

TerraPower Isotopes (TPI™) 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. TPI currently produces actinium-225 for the growing alpha therapy market and intends to expand. The TerraPower Isotopes (TPI) business 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. TPI 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. Quality Validation Specialist - TPI TerraPower Isotopes (TPI) is seeking an experienced Quality Validation Specialist to support Ac-225 production at the Everett manufacturing facility. The Quality Validation Specialist will play a critical role in establishing, implementing, and maintaining validation programs for radiopharmaceutical manufacturing operations in alignment with Good Manufacturing Practices (GMP), regulatory guidelines (FDA Title 21 CFR 210/211 and ICH Guidance), radiation safety, and company policies. The role will support equipment, facilities, utilities, computerized systems, and process validation activities while ensuring compliance with FDA, EMA, and applicable radiopharmaceutical regulatory requirements. This position is ideal for a self-directed quality professional who thrives in startup environments, enjoys building new systems, and can balance strategic program development with hands-on execution. The role will report to the Director, Quality and work closely with a multidisciplinary team including Quality Assurance, Quality Control, Operations, Engineering, R&D, and Project Management.

Requirements

Bachelor’s degree in a life sciences discipline or a related field (or equivalent qualification through experience)
Minimum 7 years of validation or quality experience in a GMP-regulated pharmaceutical or radiopharmaceutical environment under cGMP requirements
Demonstrated experience working within Quality Systems (compliant to FDA/cGMP requirements Title 21 CFR 210/211 and ICH Guidance) and providing collaborative customer support.
Hands-on experience executing equipment, facility, or process validation
Strong understanding of GMP, FDA regulations, and validation lifecycle principles
Proven ability to work independently in fast-paced or startup environments
Demonstrated experience in Computer System Validation (CSV), including validation of GxP electronic systems in accordance with GAMP 5 and 21 CFR Part 11 requirements.
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.
Excellent written and verbal communication skills, including technical writing proficiency and executive-level reporting abilities.
Strong troubleshooting, analytical, and problem-solving skills, such as those developed in fast-paced environments including the military, and other nuclear or radiopharmaceutical environments is highly preferred.
The successful candidate will possess a high degree of trust and integrity, communicate openly, and display respect while fostering teamwork.

Nice To Haves

Certification in a pharmaceutical Quality-related discipline, Lean Six Sigma, or project management training/certification is a plus.
Direct experience in radiopharmaceutical, nuclear medicine, or aseptic manufacturing
Experience building or significantly enhancing validation programs in early-stage companies
Experience supporting regulatory inspections (FDA, EMA)

Responsibilities

Design and build validation lifecycle programs, including policies, master plans, templates, and procedures
Develop and maintain Validation Master Plans (VMPs) aligned with GMP and radiopharmaceutical regulatory expectations
Establish risk-based validation approaches suitable for scaling operations.
Lead and execute IQ/OQ/PQ activities for manufacturing equipment, hot cells, cleanrooms, and critical utilities
Coordinate validation activities with Engineering, Operations, QC and Radiation Safety teams
Perform data analysis, deviation management, and validation summary reporting
Support validation of computerized systems used in GMP manufacturing and quality systems (e.g., QMS, LIMS)
Apply risk-based CSV principles in alignment with GAMP 5 and 21 CFR Part 11
Participate in deviation investigations, CAPAs, and change management related to validated systems
Ensure site validation practices align with FDA, EU GMP, ICH, and radiopharmaceutical-specific guidance
Support internal audits and regulatory inspections
Balance Quality requirements with safety, such as radiation safety, in all Quality initiatives.