MES GMBR Developer / Systems Support Specialist

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
 

MES GMBR Developer / Systems Support Specialist

Role Overview

The MES Generic Master Batch Records (GMBR) Developer / Systems Support Specialist will be responsible for the development, configuration, and testing of all components for GMBRs from initial concept to final design. This role involves leading integration development design reviews and collaborating with various departments including Business Operations, Automation, Technical Services, Validation, and Quality Assurance. The role will also support the deployment, configuration, and maintenance of the PAS-X MES system across manufacturing operations.

Key Responsibilities

• Manage the full GMBR development lifecycle for Mfg and Pkg processes, including integrating equipment management requirements, along with creating and executing test protocols based on GxP regulations and managing change control activities.

• Collaborate with Business Process Subject Matter Experts (SMEs), Business Operations, Automation, Technical Services, Validation and Quality Assurance teams to gather and analyse user requirements and process map existing workflows, ensuring that GMBR design and delivery aligns with actual business processes.

• Design, build and test all components of GMBRs from initial concept to final approval, including guiding and championing design reviews with Business Operations, Automation, Technical Services, Validation and Quality Assurance functions.

• Provide technical expertise for integrating MES System with other systems, such as ERP (SAP), Automation (Osi Pi Data Historian, PLC), and Lab Systems (LIMS), to facilitate seamless data flow and equipment interaction.

• Establish operating standards and templates for GMBR development, ensuring that consistency, re-usability, and alignment in GMBR development is consistent.

• Provide on-site and on-call support during day-to-day Business activities, which will include offering ongoing technical support, troubleshooting of issues, perform fault-finding for MES and related interfaces, and resolving interface errors / stock discrepancies.

• Diagnose and resolve system issues including latency, system configuration, interface failures, user access problems and security settings.

• Monitor MES system performance and resolve issues to minimize production downtime.

• Perform root cause analysis for MES-related incidents and implement corrective actions.

• Participate in system upgrades, patches, and validation activities.

• Liaise with Business Operations and System Owners, ensuring scheduled availability of existing equipment for the purpose of GMBR testing and training.

• Identify opportunities for continuous improvement within MES business processes and GMBR design methodologies.

• Train GMBR designers and end-users on MES integration activities, support the upskilling of existing team members, and developing job aids.

• Develop, review, and update MES Standard Operating Procedures and Design Specifications.

Qualifications

• Bachelor’s degree in IT, Computer Science, Engineering, or Pharmaceutical Manufacturing.
• Extensive experience with MES systems, notably 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.

Desired Skills

• Experience with system profile creation, reporting tools, and ITIL frameworks.
• Excellent communication and stakeholder engagement skills.
• Ability to translate paper batch records or source documents into electronic workflows.
• Ability to work in a 24 x 5 shift rotation, if required, as well as on-call.
• Ability to work independently and collaboratively in a fast-paced environment.
• Excellent verbal and written communication, presentation, facilitation and diplomacy skills.
• Highly organized, results-oriented and attentive to details.
• AI literate with exposure to Automation/OT, PLCs, SCADA.
• Self-motivated, proactive.
• High level of personal integrity consistent with Gilead’s core values.

It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company.  Except if otherwise provided by applicable law, all  employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws).  Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

Please apply via the Internal Career Opportunities portal in Workday.