Principal IT Business Analyst – GxP Manufacturing Execution Systems (MES)

Role Summary

Principal IT Business Analyst – GxP Manufacturing Execution Systems (MES) for a rapidly growing biotech organization. Focus on shaping and optimizing GxP-compliant MES to enable compliant, efficient, and scalable manufacturing operations. Lead initiatives that integrate technologies, ensure regulatory adherence, and drive operational excellence across the Seattle-based site. Provide thought leadership, define system strategies, and guide complex implementations to ensure alignment with compliance requirements and business objectives.

Responsibilities

• Define and influence MES strategy, roadmap, and governance to support long-term manufacturing goals.
• Act as the primary liaison between senior business stakeholders and IT for MES initiatives, ensuring alignment with operational and compliance priorities.
• Lead the collection, analysis, and translation of complex business requirements into functional specifications and system configurations.
• Oversee system implementation and validation activities in accordance with GxP, 21 CFR Part 11, and data integrity standards.
• Drive MES integration with ERP, automation systems, LIMS, CMMS, and other enterprise platforms to enable end-to-end digital manufacturing.
• Provide advanced troubleshooting, root cause analysis, and continuous improvement for MES-related processes and technologies.
• Develop and maintain SOPs, validation documentation, and training materials for MES systems.
• Lead upgrades, enhancements, and cross-functional projects using Agile or hybrid methodologies.
• Ensure uninterrupted manufacturing operations through proactive monitoring and escalation management for critical MES processes.
• Coach and mentor junior analysts and team members, providing guidance on best practices, compliance standards, and technical problem-solving.

Qualifications

• Required: Bachelor’s degree in Information Technology, Computer Science, Engineering, or related field (Master’s preferred).
• Required: 8+ years in IT Business Analysis or similar roles within regulated (GxP) environments.
• Required: Proven leadership in MES platforms (e.g., PAS-X, Syncade, Camstar, Siemens, Rockwell).
• Required: Deep understanding of GxP principles, Computer System Validation (CSV), and electronic records/e-signature compliance.
• Required: Strong knowledge of integration between MES, ERP, automation/historian, LIMS, and CMMS systems.
• Required: Exceptional analytical, problem-solving, and stakeholder management capabilities.
• Required: Familiarity with quality processes: Change Control, Deviations, CAPAs, Investigations, and Root Cause Analysis.

Additional Qualifications

• Experience with electronic batch records (EBR) and recipe management.
• Knowledge of biotech/pharma manufacturing processes.
• Familiarity with Agile or hybrid project methodologies.

Skills

• Strategic thinking with ability to influence and drive change across functions.
• Strong collaboration and communication skills for engaging senior stakeholders.
• Adaptability in a fast-paced, dynamic environment.
• Commitment to compliance, data integrity, and continuous improvement.
• Mentoring and talent development capabilities.

Education

• Bachelor’s degree in Information Technology, Computer Science, Engineering, or related field (Master’s preferred).

Additional Requirements

• Operational requirements relevant to manufacturing environments.