Senior IT Systems Analyst

Protingent; Bellevue (WA); On-site; USD 118,000 - 177,000; Full time

Job summary

Protingent Staffing is hiring a Senior IT Systems Analyst to engage with cross-functional teams and translate business needs into compliant system requirements across R&D, production, and finance.

You will evaluate current systems, drive integration of LIMS and ERP, and ensure data integrity with 21 CFR Part 11 compliance, including UAT and validation documentation. This is a direct-hire, on-site position in WA.

Qualifications

• Bachelor’s degree in a relevant field and 10+ years in regulated environments.
• Experience with cGMP and FDA 21 CFR Part 11.
• Exposure to export control (EAR/ITAR) compliance.

Responsibilities

• Engage with cross-functional teams to understand workflows and requirements across R&D, isotope production, sales, and finance.
• Conduct interviews, process mapping, and user story development to gather functional and regulatory requirements.
• Evaluate systems for gaps, inefficiencies, and compliance risks; translate needs into specifications and designs.
• Support selection, configuration, validation, and deployment of LIMS to ERP systems; ensure data integrity and integration.
• Develop UAT strategies and validation documentation aligning with regulatory guidelines (cGMP, FDA).
• Maintain auditability and 21 CFR Part 11 compliance; stay updated on evolving standards.
• Provide training and act as SME for laboratory, production, and quality systems.

Skills

Regulatory compliance

Requirements gathering

Documentation

Cross-functional collab

Education

Bachelor’s degree in Information Systems, Computer Science, Engineering, Life Sciences, or related field

Tools

LIMS

ERP

QMS/EBR

Job description

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: $117,922 - $176,833
• Location: Bellevue and Everett, WA.
• Export control regulations require candidates to be a U.S. Citizen, U.S. Legal Permanent Resident, or of a protected person status

#TerraProAbout 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.