MES GMBR Developer Systems Support Specialist

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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

• Bachelors 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 Gileads core values.

Equal Employment Opportunity (EEO)

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 individuals 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.

For Current Gilead Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.