Manager, IT Business Analysis

Gilead Sciences, Inc.•La Verne, CA

45d•Onsite

About The Position

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description The Senior MES Support Engineer - Manufacturing in the PDM IT organization, will be key senior team member in supporting the MES system for the La Verne, California Manufacturing site. The Senior MES Support Engineer will help lead 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 on call or different work schedules to support users at different shifts. This is an onsite role.

Requirements

Bachelor's degree in IT, Computer Science, Engineering, or Pharmaceutical Manufacturing w/ at least 6 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 4 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.
Awareness of emerging IT trends and technologies (e.g., GenAI, Digital Twin, AI/ML, 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.
Ability to work in a shift rotation and provide on-call support as needed.
AI literate with exposure to Automation/OT, PLCs, and SCADA systems.
High level of personal integrity aligned with Gilead's core values.

Nice To Haves

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 workflow configuration.
Knowledge of manufacturing processes and industry standards.
Experience leveraging AI/ML technologies in manufacturing environments.
Relevant certifications in IT, MES systems, or automation technologies.
Ability to perform system enhancements and workflow configuration updates.

Responsibilities

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.
Participate as a senior technical resource in assessing MES system requests; provide technical feedback and effort estimates.
Collaborate with IT, production, and engineering teams to implement MES solutions that improve functionality.
Mentor junior team members on business acumen, process knowledge, and compliance.
Manage and maintain the MES system (PAS-X), ensuring optimal performance and availability.
Collaborate with Technical Leads and support teams to optimize system support and user experience.
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 training sessions for end-users 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.
Assess and implement opportunities for AI, ML, and automation integration.
Collaborate with system analysts to define, analyze, and estimate technical requirements.
Analyze customer data specifications and perform gap analysis.
Draft technical design specifications and clarify implementation requirements.
Develop and adhere to integration processes for implementation and data flow.
Deploy hardware and software components and conduct unit testing.
Resolve defects identified during testing phases and execute approved change plans.
Create and update technical documentation for solution and infrastructure releases.

Benefits

This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.
Benefits include company-sponsored medical, dental, vision, and life insurance plans.
Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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