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computing. WeOperational professionals. Reporting to theHead of OperationsMES Engineerwill deploy and maintain all aspects of new MES capabilities and the continuous improvement of the system. This role will be a hands-on leader actively involved in project delivery. The individual will set the overall direction for the technical design, utilization and expansion of the MES Systems across several sites for both production and R&D.
Key Responsibilities
• Lead and own all aspects of project management and implementation activities for Manufacturing Execution System (MES) projects including requirements definition, configuration, validation and deployment and ongoing support to production and R/D across multiple sites.
• Interface with automation team and engineers for integration of SECS/GEM, RFID tracking and a variety of factory automation projects
• Deploy integrated Batch Records (eBRs), electronic Logbooks (eLogs), and other MES system functionality and UOM traceability from raw material through finished products for HVM factories
• Support the development of new capabilities required to support the transfer of new programs from Tech Dev into Manufacturing.
• Partner cross-functionally to ensure end-to-end process design and system integration to maximize operational efficiency and ensure robust testing of new configuration features based on structure risk assessments.
• Train colleagues to help construct routes, database use, SPC, front line metrics, tool and process qualification scheduling and variety of standard world class functionality
• Work cross functionally alongside Manufacturing, Engineering, Facilities, Quality, IT and other groups as required to determine business requirements and set the strategic direction
• Develop and maintain the MES roadmap including the addition of new technologies, unit operations and future technical upgrades.
• Develop and maintain GMP and ISO system documentation and manage supporting compliance activities to ensure that all proper documentation for compliance is developed and delivered in a timely manner.
• Ensures projects are executed on time, within budget and meet pre-established goals
• Communicates system changes and issues to relevant stakeholders
• Be an advocate for Lean and Muda elimination
Functional Knowledge
Deploying and sustaining MES
cGMP and manufacturing operations and practices
Good automation Manufacturing Practices (GAMP) and Computer System Validation (CSV).
Computer programming and debugging skills pertinent to the system requirements
Experience with a variety of MES systems and down selection of vendors
Business Expertise
Anticipates business and regulatory issues; recommends product, process or service improvements
Leadership
Leads projects with notable risk and complexity; develops the strategy for project execution
Problem Solving
Solves unique and complex problems with broad impact on the business; requires conceptual and innovative thinking to develop solutions
Impact
Impacts the direction and resource allocation for program, project or services; works within general functional policies and industry guidelines
Interpersonal Skills
Communicates complex ideas, anticipates potential objections and persuades others, often at senior levels, to adopt a different point of view
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