Manufacturing Systems Specialist - St Louis, United States - bioMérieux SA
Description
Position Summary:
The MES Applications Specialist role is to be part of the Engineering and Production Support team which is responsible for design, configuration, enhancement, operation and support/troubleshooting of the Manufacturing Execution System (MES) Operations Platform adopted by bioMérieux, such as Tulip MES Software.
The specialist will interface with appropriate stakeholders and cross functional groups to build the digital work instructions, test instructions, DHRs and processes that support Instrument assembly and records generation.
The position is also expected to guide deployment activities at the department level that are planned with and by the regional project manager.
The specialist will participate in documentation and validation efforts as the systems are brought online in bioMérieux's regulated manufacturing environments.
Primary Duties:
Executes project assignments from the beginning to successful completion and implementation with a minimum of direct supervision.
The position is responsible for helping scope their specific roles in the project to support business goals in collaboration with other members of the Operational Technology team and project stakeholders.
Scope, design, deploy, and manage production ready applications using the operations platform (Tulip is no-code development ).Interpret and convert work instructions to digital equivalents.
Track and implement change requests, errors, issues, and requirements logged against Tulip assembly applications/documentation.Responsible for consolidating and reconciling all comments and inputs from production personnel, Engineering and others and incorporating these inputs into the appropriate documentation.
Interface with the Tulip MES and Manufacturing Network Administrator(s) in the Operational Technology team to properly implement operator interface elements and data collection points, and assist with troubleshooting.
Use design control and associated change management systems and other change processes as defined by Company procedures and the FDA Quality Systems Regulations.
Maintain compliance with the design control guidelines and Quality requirements within the company's regulated ISO\ FDA environment.Education and Experience:
Associate's Degree2+ years of experience in a medical device manufacturing environment or related industry is preferred.
Manufacturing and assembly processTechnical publicationsProject coordinationIntegration of manufacturing and test softwareExperience with Tulip MES Operations Platform preferred.
Experience with SolidWorks Composer is a plus.
Experience with any type of programming or coding language is a plus.
Experience training users how to navigate an Application is preferred.
Knowledge, Skills and Abilities:
Project management and communicationTechnical writingStrong organizational skillsWork well as an individual or as part of a teamUnderstanding of SQL or SQL-like RDMS database design and use is a plusQuality and completeness of documentationDevelopment of personal autonomyKnowledge of electro/mechanical production processesProficiency in Microsoft Office SuiteKnowledge of FDA, QSR and ISO quality systems
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Job ID: 35462
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