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.

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.

Key Qualifications and Skills

• 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
• Certification in a pharmaceutical Quality-related discipline, Lean Six Sigma, or project management training/certification is a plus.
• 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.

Preferred Qualifications

• 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)

Job Functions:

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 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
• Work Conditions: Stairs, typing/keyboard, standard and/or sitting working environment of >8 hours/day
• Travel required 0-10%

Job details

Job Type: Full-time

Salary Range: $117,922 - $176,883

*We typically place offers in the lower to middle portion of the range to maintain internal equity and allow room for growth. Any salary offered within the posted salary band is based on market data and commensurate with the selected individual's qualifications experience. This range is specific to Washington State.

Benefits:

• Competitive Compensation
• Salary, eligible to participate in discretionary short-term incentive payments
• Comprehensive Medical and Wellness Benefits for family or individual
• Vision
• Dental
• Life
• Life and Disability
• Gender Affirmation Benefits
• Parental Leave
  • 401k Plan
  • Generous Paid Time Off (PTO)
• 21 days of annually accrued PTO
  • Generous Holiday Schedule
• 10 paid holidays
• Relocation Assistance
• Professional and Educational Support Opportunities
• Flexible Work Schedule

Please visit https://www.terrapower.com/careers/ to apply