Manufacturing Systems Engineer

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Position Summary & Role

The Manufacturing Systems Engineer is a business process representative in Manufacturing working with Quality and Digital to implement the automation strategy for MES and other system integrations to MES.  The Manufacturing Systems Engineer will facilitate change, continuous improvement, validation, implementation, operation and maintenance of MES within Cell Therapy and Viral Vector Manufacturing at **MEMBERS ONLY**SIGN UP NOW***.’s manufacturing facility in East Norriton, PA.  The Manufacturing Systems Engineer will collaborate with peers across departments to ensure completion of projects.

Job Responsibilities

• Support MES implementation/deployment and modifications for Manufacturing.

• Provide Subject Matter Expert support to projects for process design and operation of MES functionality.

• Coordinate with Manufacturing, Digital and Quality to ensure the successful implementation and management of MES changes at site.

• Lead MES technology transfer and new product introduction activities into Manufacturing and provide continued support throughout manufacturing campaigns.

• Convert manufacturing business requirements into functional electronic workflows.

• Steward MES master data including Material Master, Bill of Materials, Configurations, Electronic Batch Record (eBR), Worksheets, Bill of Testing and Bill of Equipment.

• Lead system testing and validation for Manufacturing with Digital and Quality departments.

• Write and maintain MES Standard Operating Procedures and User Requirement Specifications for Manufacturing.

• Initiate MES related change controls for Manufacturing.

• Train manufacturing users on MES use.

• Troubleshoot MES eBR use and transactions and escalate issues to Digital.

Preferred Experience, Education & Qualifications

• Bachelor of Science degree in an Engineering or IT discipline.

• 5+ years of Biomanufacturing experience required. Cell and Gene Therapy experience strongly preferred.

• 2+ years experience with MES administration and/or implementation, preferably POMSnet Aquila.

• Project management and change management experience associated with GxP Digital Systems.

• Working knowledge of current Good Manufacturing Practice and Good Automation Manufacturing Practices including Computer System Validation.

• Fluency in supporting the digitization of manufacturing & engineering business processes.

Other Ideal Personal Characteristics:

• Fluid collaboration skills across business, Digital and vendors

• Builder mentality that seeks to produce innovation, agility, and velocity to support business-as-usual operations and new project implementation.

• Demonstrates a ‘get things done’ attitude and inspires others to perform at a high level.

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