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Senior IT Systems Analyst
15800 Northup Way Bellevue, WA 98008 US
Job Description
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
- 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
- Direct Hire
- Salary Range: $117,922 - $176,833
- Location: Bellevue and Everett, WA
- Travel Required: 0-10%
- Export control regulations require candidates to be a U.S. Citizen, U.S. Legal Permanent Resident, or of a protected person status
Benefits Package: Protingent offers competitive salaries, insurance plan options (HDHP plan or POS plan), education/certification reimbursement, pre-tax commuter benefits, Paid Time Off (PTO), and an administered 401k plan.
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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