Senior IT Systems Analyst – Regulated Labs, LIMS & ERP

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

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.