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The Novato MES Senior Systems Analyst is responsible for administering and configuring the MES application, managing user access, and executing validation protocols. This role involves collaborating with IT infrastructure for system setup, supporting MES infrastructure issues, and engaging with vendors for system analysis, migration, and updates. The analyst manages interfaces between MES and other systems like SAP and LIMS, develops and executes test protocols, and leads technical support and troubleshooting efforts. Additional duties include overseeing documentation, supporting audits and inspections, leading deviation investigations, implementing application changes, and contributing to MES enhancements and project deployments.
Job Responsibility:
MES application administration, user management, application configuration and execution of IQ/OQ protocols for MES System Master Data and configuration
Work closely with IT Infrastructure team on configuration and setup of MES infrastructure, databases and installation of Third-Party Applications
Configuration and management of MES Level 4 Interfaces to SAP and LIMS and any other applications that are integrated with MES
Creation and execution of test protocols for application changes and for Level 2, Level 3 and Level 4 interfaces to MES
Development of test MBRs, master data and system master data to support validation testing
Creation and management of MES configuration documents and IT administration SOPs and work Instructions
Attends workshops and meetings with MES vendor for FIT Gap analysis, MES migration preparation activities, application changes or hotfixes and any other application specific activities that require vendor consultation
Assist with and support any site Inspections, internal audits and any queries relating to MES application
Participate in and support MES FAT and SAT activities onsite or at vendor site
Support MES Core and IT Level 4 team in troubleshooting interface issues and any application issues affecting performance and execution on the MES application by end users
Configuration setup and validation of Electronic Data Interchange (EDI) queries and other external data tools such as PowerBI
Leads technical support effort for IT related issues in the MES application and its interfaces
Assist and lead deviation investigations and corrective actions relating to MES application and Level 4 interfaces
Implement application changes and enhancements using standard BioMarin change control processes
Achieve project deliverables for additional MES phases and deployments working closely with other team members and with the MES vendor
Contributes to additional enhancements and improvements to MES application to meet business requirements or resolve application issues and end-user experience
Work closely with the Validation team for execution of validation protocols and test scripts
Monitors systems message traffic and other MES health indicators. Constructing, generating and providing reports to business partners, as required
Other duties, as assigned
Requirements:
3-5 minimum years of industry experience
>2 years in a similar role
Familiarity with the Körber PAS-X MES software
Technical writing skills to author and/or edit configuration specifications or system design documentation
Strong technical background and ability to navigate IT systems and infrastructure
Ability to lead discussions and troubleshoot electronic systems and flow of information across systems
Strong communication skills
BA or BS in a science or engineering field (or equivalent experience)
Nice to have:
5+ desired number of years of industry experience
3-5 years in a similar role
Familiarity with Sap S4/Hana ERP systems
What we offer:
Discretionary annual bonus
Discretionary stock-based long-term incentives
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans
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