Sr IT Business Analysis Specialist

Описание вакансии

The MES Support Engineer – Manufacturing in the PDM IT organization, will be key team member in supporting the MES system for the La Verne, California Manufacturing site.

The MES Support Engineer will be part of a core team of IT support that directly interacts with users from different functional areas such as Manufacturing, Packaging, QA, etc. This will include core functionality support related to GMBR, ESPs, and digital workflows within MES. Meeting the agreed upon response and service level agreements with business objectives will be a critical measure of success.

The role will be involved with keeping core MES application and servers operational along with troubleshooting interfaces with SAP and other integrated systems with MES. Since manufacturing is 24/7, role will be expected to work oncall or different work schedules to support users at different shifts.

Key Responsibilities

Business Knowledge & Relationship Management

• Cultivate and apply working knowledge of Manufacturing, Facilities & Engineering, and Quality Control operations.
• Enhance GMP knowledge through Gilead’s 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.

Operational Support & Troubleshooting

• 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.

Basic Qualifications

• Bachelor’s degree in IT, Computer Science, Engineering, or Pharmaceutical Manufacturing w/ at least 5 years of relevant experience with MES systems, preferably Körber PAS-X OR Master's degree in IT, Computer Science, Engineering, or Pharmaceutical Manufacturing w/ at least 3 years of relevant experience with MES systems, 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 emerging technologies such as 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.

Preferred Qualifications

• Strong organizational skills with attention to detail; self-motivated and proactive.
• Solid understanding of GMP compliance and 21 CFR Part 11 requirements.
• Quality-oriented mindset with alignment to IT compliance and cGMP regulations.
• Experience with PAS-X MES software and manufacturing industry standards.
• Exposure to AI/ML technologies and their application in manufacturing.
• Relevant certifications in IT, MES systems, or automation technologies.