Senior IT Business Analyst - GxP Systems Integration (Boomi)

Role Summary

Senior IT Business Analyst to drive integration projects and ensure GxP-compliant system integration using Boomi, based in Seattle, WA.

Responsibilities

• Act as the liaison between business stakeholders and IT for integration-related initiatives at Seattle location.
• Gather, analyze, and document business and technical requirements for system integrations.
• Design and support integration workflows using Boomi and related tools.
• Ensure integrations comply with GxP, 21 CFR Part 11, and data integrity requirements.
• Collaborate with Quality Assurance to validate integration solutions and maintain compliance documentation.
• Troubleshoot and resolve integration issues, coordinating with vendors and internal teams.
• Develop and maintain integration process documentation, SOPs, and training materials.
• Participate in system upgrades, enhancements, and integration projects across ERP, LIMS, MES, CMMS, and other GxP systems.
• Provide 24/7 support for critical integration processes as needed to ensure uninterrupted operations.

Qualifications

• Education: Bachelor’s degree in Information Technology, Information Systems, Computer Science, Engineering, or related field.
• Experience: 5+ years as an IT Business Analyst or similar role in a regulated (GxP) environment.
• Hands-on experience with Boomi or similar integration platforms (e.g., MuleSoft, Informatica, SAP CPI).
• Strong understanding of GxP principles, CSV (Computer System Validation), and regulatory compliance.
• Excellent analytical and problem-solving skills.
• Strong communication and stakeholder management abilities.
• Familiarity with integration between ERP, LIMS, MES, CMMS, and other GxP systems.
• Familiarity with quality processes including Change Control, Discrepancies and Deviations, CAPAs, Investigations and Root Cause Analysis.

Skills

• Analytical thinking, problem-solving, and effective communication.
• Stakeholder management and requirement gathering.
• Experience with ERP, LIMS, MES, CMMS integration.

Education

• Bachelor’s degree in Information Technology, Information Systems, Computer Science, Engineering, or related field.

Additional Requirements

• Experience with system validation documentation.
• Knowledge of data mapping, API integrations, and middleware best practices.
• Familiarity with Agile or hybrid project methodologies.
• Knowledge of manufacturing and laboratory processes in biotech/pharma.