This position requires an individual who must work with minimal supervision to support change and configuration activities of products from inception through end-of-life. The primary focus is the support and iteration of Camstar Manufacturing Execution System (MES) models, leveraging deep system functionality to meet business needs. This person will join a dynamic, fast paced organization supporting new product development teams, as well as sustaining operations. This person is responsible for compiling relevant information related to product and process definition, analyzing business and compliance requirements, assessing risks for impact, and procuring accurate information for use in global systems. Additional tasks include identification and participation in product and process improvements initiatives, as well as management of Engineering Change Requests and Change Orders (ECRs/ECOs) in PLM.
* Drive improved utilization of MES for a manufacturing area with respect to both configuration and core functionality, and act as "voice of the customer" for manufacturing
* Support and iterate models in MES to develop and optimize manufacturing process flows
* Engage Subject Matter Experts (SMEs) to assure change and configuration documentation is accurate and complete, all relevant documentation is included, and appropriate implementation strategies and validation activities have been completed.
* Understand and provide guidance for use of master data along with the roles played by PLM, ERP, MES, LIMS, etc. in support of manufacturing
* Review, monitor, and drive implementation activities as needed to ensure the change has been completed properly
* Responsible for the accuracy of system data through process evaluation and validation
* Identify, execute, and support process improvement initiatives of varying complexity engaging global, cross-functional support
* Able to work independently and requires minimal guidance to perform required tasks
* Work with peers and/or subordinates to ensure timely completion of projects and tasks
* Take initiative to develop and implement new processes to strengthen data accuracy or enhance efficiency
* Demonstrate effective communication style working with all levels of organizational structure, through multiple departments, and across global sites
* Provide guidance and training related to MES and other production systems to stakeholders and cross-functional team members
* Provide leadership to junior level engineers
All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
* Direct hands on experience creating and supporting modeling in MES, Camstar MES preferred.
* Proven ability to convert process flows into automated workflow models
* Technical background in manufacturing, preferably in a life sciences, diagnostic, and/or medical device environment
* Experience in configuration management, operations, and/or quality within a regulated industry
* Hands-on experience with 3rd Party interfaces that are commonly interfaced with MES applications like ERP, PLM, LIMS, SCADA, Equipment, etc.
* Solid understanding of computer system and manufacturing validations
* Experience with Software Development Life Cycle of controlled systems preferred
* Experience with process and material change and configuration activities within an Enterprise Resource Planning (ERP) system, SAP preferred
* Product Lifecycle Management (PLM) experience, SAP desirable
* Experience with ISA-95 with a strong understanding for the boundaries between enterprise and control systems
* Working knowledge of ISO 13485 and cGMP requirements desired
* High degree of initiative and ownership, as well as a proven history of delivering results while working with several different departments in a fast-paced environment
* Typically requires a minimum of 5 years of related experience with a Bachelor's degree
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