Sr IT Business Analysis Specialist

Role Summary

Sr IT Business Analysis Specialist at Gilead. The MES Support Engineer – Manufacturing in the PDM IT organization will be a key team member in supporting the MES system for the La Verne, California Manufacturing site, interfacing with multiple functional areas and ensuring system operations align with GMP and regulatory requirements.

Responsibilities

• Cultivate and apply working knowledge of Manufacturing, Facilities & Engineering, and Quality Control operations.
• Enhance GMP knowledge through Quality systems, validation strategy, SDLC approach, and testing methodology.
• Establish and maintain relationships with functional stakeholders to support business operations.
• Assess MES system requests for business need and technical feasibility; provide feedback and effort estimates.
• Collaborate with IT, production, and engineering teams to implement MES solutions that improve functionality.
• Manage and maintain the MES system (PAS-X), ensuring optimal performance and availability.
• Diagnose and resolve MES and SAP integration issues; act as the SAP point of contact for MES-related troubleshooting.
• Plan and execute system upgrades, patches, and enhancements.
• Conduct end-user training and maintain documentation of system configurations and procedures.
• Ensure MES compliance with industry standards and regulatory requirements.
• Provide on-site and on-call support during manufacturing activities.
• Perform root cause analysis for MES incidents and implement corrective actions.
• Participate in validation activities (IQ/OQ/PQ) and ensure compliance with GxP, GAMP, and 21 CFR Part 11.
• Maintain audit trails and documentation for inspections.
• Support MES workshops, design phases, and change management planning.

Qualifications

• Bachelor’s degree in IT, Computer Science, Engineering, or Pharmaceutical Manufacturing with at least 5 years of relevant MES experience (preferably Körber PAS-X) orMaster’s degree with at least 3 years of relevant MES experience (preferably Körber PAS-X).
• Strong understanding of pharmaceutical manufacturing processes and MES lifecycle.
• Experience with SAP-MES integration and Level 2 automation systems.
• Familiarity with ISA-95/S88 standards and MES architecture.
• Exposure to GenAI, Digital Twin, AI/ML, and Process Analytical Technology.
• Experience with system profile creation, reporting tools, and ITIL frameworks.
• Excellent communication and stakeholder engagement skills.
• Ability to work independently and collaboratively in a fast-paced, 24/7 environment.

Skills

• MES systems administration and troubleshooting
• SAP-MES integration and interfaces
• Regulatory compliance (GxP, 21 CFR Part 11) and validation (IQ/OQ/PQ)
• Documentation, training, and change management
• Strong communication and cross-functional collaboration

Education

• Bachelor’s degree in IT, Computer Science, Engineering, or Pharmaceutical Manufacturing; Master’s degree preferred for advanced roles.

Additional Requirements

• On-site and on-call support required due to 24/7 manufacturing operations.
• Willingness to work different schedules to support manufacturing shifts.