Senior IT Systems Analyst

Senior IT Systems Analyst 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 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 ranging 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. #J-18808-Ljbffr Protingent