TerraPower.

Quality Validation Specialist/Senior Specialist

Everett, WA · Senior · Full-time

Sponsorship not specified$118k-$177kDetected 26 days ago

Data AnalysisProject ManagementProcess ImprovementGMPFDA RegulatoryCommunicationProblem SolvingWritingLean ManufacturingGxP

About the role

TPI currently produces actinium-225 for the growing alpha therapy market and intends to expand.
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.
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.

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
Lead and execute IQ/OQ/PQ activities for manufacturing equipment, hot cells, cleanrooms, and critical utilities
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)
Support internal audits and regulatory inspections
Demonstrated experience working within Quality Systems (compliant to FDA/cGMP requirements Title 21 CFR 210/211 and ICH Guidance) and providing collaborative customer support.
Experience building or significantly enhancing validation programs in early-stage companies

Minimal, with ability to safely lift up to 25 pounds.
Travel required 0-10%
Bachelor's degree in a life sciences discipline or a related field (or equivalent qualification through experience)
Strong understanding of GMP, FDA regulations, and validation lifecycle principles
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.

Direct experience in radiopharmaceutical, nuclear medicine, or aseptic manufacturing
Experience supporting regulatory inspections (FDA, EMA)
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.
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

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.
$117,922 - $176,883
Salary, eligible to participate in discretionary short-term incentive payments

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