Senior IT Systems Analyst

TerraPower•Bellevue and Everett, WA

About The Position

TerraPower 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.

Requirements

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

Nice To Haves

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

Responsibilities

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