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Senior IT Systems Analyst

Protingent

Bellevue, WA

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JOB DETAILS
SALARY
$117,922–$176,833 Per Year
SKILLS
Acceptance Testing, Aerospace and Defense, Analysis Skills, Artificial Intelligence (AI), Automation, Biology, Business Administration, Business Analysis, Business Skills, Clean Technologies, Code of Federal Regulations, Communication Skills, Computer Science, Corrective Action, Cross-Functional, Current Good Manufacturing Practice (cGMP), Customer Support/Service, Data Quality, Documentation, ERP (Enterprise Resource Planning), FDA (Food and Drug Administration), GxP, Identify Issues, Information Technology & Information Systems, Interviewing Skills, Laboratory Information Management System (LIMS), Legal, Manufacturing, Medical Equipment, Nuclear Medicine, Organizational Skills, Process Improvement, Process Validation, Production Systems, Project Management Professional (PMP), Quality Management, Regulations, Regulatory Compliance, Regulatory Requirements, Requirements Management, Research & Development (R&D), Sales, Systems Analysis, Systems Engineering, Systems Maintenance, Technical Training, Test Plan/Schedule, Test Scripts, Test Strategy, Traceability, United States Citizen, Validation Documentation, Willing to Travel
LOCATION
Bellevue, WA
POSTED
13 days ago
Position Title: Senior IT Systems Analyst

Position Description: Protingent Staffing has an exciting FTE Senior IT Systems Analyst opportunity.

Job 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 requirement
  • 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.

Job Qualifications:
  • 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.

Preferred Job Qualifications:
  • 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.
  • Travel Required: 0-10%.

Job Details:
  • Job Type: Direct Hire
  • Salary Range:
    • Level 10: $117,922 - $176,833 
    • Level 11: $138,685 - $208,027
  • Location: Bellevue OR Everett, WA.
  • Export control regulations require candidates to be a U.S. Citizen, U.S. Legal Permanent Resident, or of a protected person status
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About Protingent: Protingent is an Award-Winning provider of top-tier Engineering and IT talent, trusted by companies at the forefront of innovation — from Software and Aerospace to AI, Clean Tech, Medical Devices, and Connected Technologies. We’re passionate about making a positive impact by connecting exceptional talent with meaningful opportunities and helping our clients build the future.

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