- Engage with cross-functional teams to understand workflows, challenges, and opportunities across R&D, isotope production, sales, and financials
- Conduct interviews, process mapping, and user story development to gather functional and regulatory requirements
- Evaluate current systems and processes for gaps, inefficiencies, compliance risks, and areas for improvement
- Translate business needs into clear requirements, specifications, and solution designs
- Support the selection, configuration, validation, and deployment of enterprise systems which range from Laboratory Information Management Systems (LIMS) to ERP
- Partner with vendors and internal resources to implement new solutions, ensuring scalability, data integrity, and integration with existing platforms
- Develop user acceptance testing (UAT) strategies, test scripts, and validation documentation in alignment with cGMP and FDA guidelines
- Ensure systems maintain auditability, traceability, and compliance with 21 CFR Part 11 and related regulatory requirements
- Maintain awareness of evolving regulatory standards and ensure systems remain compliant
- Serve as a trusted advisor and subject matter expert for laboratory, production, and quality systems
- Troubleshoot system issues, document root causes, and drive corrective and preventive actions
- Recommend process improvements, automation opportunities, and new technologies to strengthen operational reliability and efficiency
- Develop training materials and deliver end-user training for new or updated systems
- Bachelor's degree in Information Systems, Computer Science, Engineering, Life Sciences, or a related field
- 10+ years of experience as a Systems Engineer, Systems Analyst, Business Analyst, or similar role supporting regulated manufacturing or laboratory environments
- Strong understanding of cGMP, FDA 21 CFR Part 11, data integrity principles, and regulated manufacturing practices
- Familiarity with export control frameworks (e.g., EAR, ITAR) and related compliance requirements
- Experience gathering requirements, writing specifications, mapping processes, and supporting enterprise system implementations
- Excellent communication skills with ability to translate technical concepts for non-technical stakeholders
- Strong analytical, organizational, and documentation skills
- Experience in nuclear medicine, radiopharmaceutical production, medical isotopes, or other highly regulated scientific environments
- Experience supporting Quality Management System (QMS) or Electronic Batch Records (EBR) platforms in addition to LIMS
- MBA focused on related industry business acumen a plus
- Project Management Professional (PMP) certification a plus
- Knowledge of Good Practice (GxP) validation methodologies, including IQ/OQ/PQ
- 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.
- 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
- 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
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Senior IT Systems Analyst - Bellevue - TerraPower
Description
TITLE:
Senior IT Systems Analyst
LOCATION:
Everett, WA / Bellevue, WA
The TerraPower Isotopes (TPITM) division has been established to pursue medical isotopes developmentadvancing nuclear science for significant human health benefits.
We seek to support revolutionary radiotherapies for treatments of various cancers through the supply of radioisotopes.TerraPower currently has unique access to a supply of thorium for the long-term production of actinium-225 in the growing alpha therapy market and intends to expand into other nuclear related medical treatments.
The TerraPower Isotopes (TPI) program 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.
TerraPower 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.
In addition, as a federal contractor, TerraPower has instituted an Affirmative Action Plan (AAP) to proactively recruit, hire, and promote women, minorities, disabled persons and veterans.
Senior IT Systems AnalystTerraPower is seeking a Senior Systems Analyst to support our rapidly growing medical-isotope generation and radiopharmaceutical manufacturing operations.
This role is responsible for evaluating business processes, capturing detailed requirements, supporting system design and selection, and ensuring the successful implementation of compliant, reliable, and scalable digital solutions.
The Senior Systems Analyst will work closely with Quality, Manufacturing, R&D, Legal, Compliance and IT to ensure systems meet cGMP, FDA 21 CFR expectations, export control requirements, and industry best practices.
This is a hands-on, high-impact role ideal for someone who excels at understanding complex scientific and manufacturing workflows and translating them into technical application requirements.
Key Responsibilities:
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 and/or standing 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:
Occasional
Special Senses:
Visual and audio focused work
Work Conditions:
Stairs, typing/keyboard, standard and/or sitting working environment of >8 hrs./day
Travel required: 0-10%
TerraPower's technology is controlled for export by various agencies of the U.S. Government.
TerraPower must evaluate applicants who are foreign nationals (other than asylees, refugees, or lawful permanent residents) in accordance with U.S.
Government export control requirements.To facilitate TerraPower's export control reviews, you will be asked as part of the application process to identify whether you are a U.S.
Citizen or national, asylee, refugee, or lawful permanent resident of the United States. Government export authorization approval times vary.Based on business needs for a particular position, TerraPower may not consider a foreign national from a country if it is impracticable to obtain timely Government export approval.
Job details:
Salary Range 10:
$117,922 - $176,833
Benefits:
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