US-MA, Single Use Engineer Manager SR0033270-MZ
Single Use Engineer Manager will have a key role towards the successful design, implementation and deployment of sound business processes for the Lexington site operations. He/she performs work independently and in alignment with pre-defined goals and business objectives, will help the organization realize its vision for the future, and will have the potential to become an expert in the field.
Work in alignment with best practice methodology and industry standards, per regulatory and compliance, for the design of business processes that may include electronic system implementations, Participate and lead discussions to collect and define current and future process workflows, Champion single-use process and program harmonization across the Massachusetts biologics organization (MBO) and act as an ambassador of the site s single-use solutions with other sites throughout the organization. Gain knowledge and apply previous experience to define user requirements and system configurations, Coordinate validation and deployment/implementation activities, and Maintain new systems, processes, or materials introduced to sustain process improvements Own, support and facilitate changes and improvements through quality systems such as Change Controls, Corrective and Preventative Actions (CAPAs), Supplier Notifications of Change, Engineering Change Management. Support use and/or maintenance of manufacturing technology systems such as Simca, Infor, Statistica, PI historian, etc.
Participate in the implementation, improvement and deployment of manufacturing processes/systems. Provide expertise and guidance to implementation of new single-use technologies and work with stakeholders to improve and streamline the process of single-use implementation and use. He/she will coordinate workshops and provide inputs as part of feasibility/front end studies, detailed system design, product technology transfers and project implementations.
In alignment with the objectives of the Biologics Ops Unit of Technical Operations and the Massachusetts Biologics Operation, participate in ongoing efforts ensuring timely completion of tasks. Act as an operation s SME and spokesperson, providing process overviews and inputs from the process perspective, while ensuring that the deliverables meet the business needs of the manufacturing organization. Interact with cross-functional teams including but not limited to Manufacturing, Facilities and Engineering, Quality, Validation, Operational Excellence & Training, Supply Chain and Technical support teams (Process Development and Manufacturing) and Tech Ops to collect, analyze and describe relevant information, per business priorities and established data strategy.
Train on relevant industry standards for systems, learn Takeda s Biologics manufacturing and business operations (end-to-end), attend and present at industry conferences on relevant manufacturing systems and processes and become familiar with the current and future systems landscape.
Mentor and train junior team members.
Education and Experience Requirements
Other Job Requirements
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