Flex Factory Process Design Engineer

GE (NYSE: GE) is the world’s Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. GE is organized around a global exchange of knowledge, the "GE Store," through which each business shares and accesses the same technology, markets, structure and intellect. Each invention further fuels innovation and application across our industrial sectors. With people, services, technology and scale, GE delivers better outc

The Flex Factory Process Design Engineer is accountable for the design of the customized Flex Factory single-use manufacturing, automated equipment assembly, ensuring that the following are met: applicable regulatory requirements; optimized performance for the customer’s process, operation, and facility design, layout and regional location; and design compliance.

• The FlexFactory design includes generation of relevant design documents including PFDs, equipment lists, utility requirements, process descriptions, FlexFactory equipment URSes, equipment configurations and design approval packages for the components of the FlexFactory. Generation of the design and related documents requires the Design Engineer to interface and coordinate with a cross-functional team of engineers, process designers and customers to synthesize the customer needs into feasible, reliable and profitable macro level design that increases cell processing and manufacturing throughput to industry leading levels.

• Has overall design responsibility for the FlexFactory equipment, consumable and accessory selection and specification, utility requirements, automation requirements, design documentation generation, testing protocol review and approval

• Lead the design team and design control process from requirements development and design planning to final design approval by customer
• Ensure applicable customer URS requirements can be met by the FlexFactory design, that they are approved, tracked and the requirements are met by design and ultimately fulfilled by the end product.
• Initiate the FlexFactory equipment product code registration
• Lead System Designer for the FlexFactory build project
• Support Manufacturing (Documentation Group) to ensure the completeness of the TOP
• Support Manufacturing & QC for setup of equipment for Functional Testing & FAT
• Support Customers questions/issues during the FAT
• Manage FAT deviation punch list
• Ensure regulatory fulfillment of delivered products
• Represent GE and FlexFactory in technical discussions with customers during the project
• Participate in Enterprise Solutions (ES) project meetings as required
• Feedback learnings, operational gaps, product improvements, etc. to Enterprise Solutions Product Manager
• Visit and participate in customer audits of sub suppliers (supports QA).
• Coordinate the detailed design and solve any design issues during the design phase
• Provide engineering support to manufacturing
• Assist with on-the-floor support and training to users of FlexFactory equipment
• Reviews and contributes to improve Ways of Working, including instructions
• Maintains awareness of industry standards and GMP's
• Participates in developing and updating the FlexFactory project schedule
• Acts as a contract for desing
• - related questions Quality Specific Goals:
• Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
• Complete all planned Quality & Compliance training within the defined deadlines
• Identify and report any quality or compliance concerns and take immediate corrective action as required
• Ensure compliance/closure of Regulatory and Quality requirements before approving Design Control FDRs and NPI program milestones
• Lead continuous improvement activities by driving the implementation of process and product quality improvement initiatives

• BS degree in biochemical / chemical engineering or a related engineering/life science discipline
• Minimum of 5 years’ experience with process development, technical transfer capacity or manufacturing scale bioprocess facility.
• Experience in design and/or operation of biopharma processes and unit operations
• Experience in working within cross functional teams

Desired Characteristics:

• 2 years of direct experience working in a pilot plant
• Master's Degree
• Disposable design and application experience preferred
• Experience with AutoCAD, Visio, MS Project
• Detail oriented, excellent at critical analysis and problem solving
• Experience working with global business environment with sound understanding of global processes.
• Open to a changing environment
• Team oriented