Quality Validation Specialist/Senior Specialist
Nuclear industryUS only
About this role
Quality Validation Specialist role supporting Ac-225 radiopharmaceutical production at TerraPower Isotopes' Everett facility. You'll establish and maintain validation programs aligned with GMP and FDA regulations, balancing strategic program development with hands-on execution in a startup environment.
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
Qualifications
- —Bachelor's degree in a life sciences discipline or 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
- —Hands-on experience executing equipment, facility, or process validation
- —Strong understanding of GMP, FDA regulations (Title 21 CFR 210/211), and validation lifecycle principles
- —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 ability to interpret federal regulations, guidance, and standards
- —Excellent written and verbal communication skills, including technical writing proficiency and executive-level reporting abilities
- —Proven ability to work independently in fast-paced or startup environments
- —Demonstrated experience within Quality Systems compliant to FDA/cGMP requirements and providing collaborative support
Desired
- —Certification in a pharmaceutical Quality-related discipline, Lean Six Sigma, or project management training/certification
- —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)
- —Strong troubleshooting, analytical, and problem-solving skills developed in fast-paced environments including military, nuclear, or radiopharmaceutical settings
Apply on TerraPower →
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Job details
FieldAdministrative
LocationEverett, WA
IndustryNuclear energy
PostedJun 2026
About the company
TerraPower →A nuclear innovation company founded by Bill Gates, building the Natrium sodium-cooled fast reactor and advancing medical isotope production.
Careers page ↗Quality Validation Specialist/Senior Specialist
TerraPower