Quality Validation Specialist/Senior Specialist
TerraPowerEverett, WA$118k–$177k/yr
Credentials that matter
Skills and tools
- Radiopharmaceutical
- Radiation Protection
- cGMP
- CSV
Required 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
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
Preferred qualifications
- 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
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Quality Validation Specialist/Senior Specialist
TerraPower · $118k–$177k/yr