Role Summary:
participate in process and system design for the FlexFactory single-use manufacturing system and other similar subsets of GE Bioprocess manufacturing technologies. The PE will be responsible for the process and system design of the FlexFactory, automated equipment assembly, and will ensure compliance with the applicable regulatory requirements; optimized performance for the customer’s process, operation, facility layout and regional location.

Essential Responsibilities:
The Project Engineer will be responsible to support process and system design which includes but not limited to the generation of relevant design documents including Process Flow Diagrams (PFDs), equipment lists, utility requirements, process descriptions, user requirements specification (URS), general specification (GS), equipment configurations and design approval packages. The Project Engineer will be responsible for providing feasible, reliable and profitable macro level design based on customer needs and regulatory requirements.
Has responsibility for the support of design and implementation of FlexFactory equipment, consumable and accessory selection and specification, utility requirements, automation requirements, design documentation generation, testing protocol review and approval.
Support the design control process from requirements development and design planning to final design approval by customer.
Ensure applicable customer requirements specification (URS) can be met by the FlexFactory design, and ultimately fulfilled by the end product.
Interface and coordinate with a cross-functional team of engineers, Process Design Engineers and customer.
Support to ensure the completeness of the TOP, equipment set-up for Functional Testing & FAT.
Support Customers questions/issues during Factory Acceptance Test (FAT) and manage FAT deviation punch list.
Coordinate the detailed design and solve any design issues during the design and implementation phase and acts as a contact for system design related questions.
Participates in developing and updating the project schedule.
Support customer meetings by providing system hardware understanding. Develop, explore and recommend manufacturing concepts to fit customer needs/facility requirements.
 Assure compliance 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
 Work closely with Customer’s Subject Matter Experts (SMEs) to ensure continuous exchange of critical and technical information needed to execute design activities on time
 Complete all planned Quality & Compliance training within defined deadlines
 Identify and report any quality or compliance concerns and take immediate corrective action as required
 Work closely with Process Design Engineers to ensure that the equipment specification meets customer and process needs, and that equipment layout is optimized for the customer facility.
 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
 Approximately 30% travel depending on project specifics and geographic location

Qualifications/Requirements:
 BS or MS degree in biochemical / chemical engineering or a related engineering/life Science discipline
 Minimum of 5 years of relevant bioprocess/technical experience
 Working knowledge of pharmaceutical/biotech processes, equipment hardware, and single use technology
 Engineering background in problem solving
 Thorough knowledge of biologics CMC, cGMP manufacturing requirements
 Technical understanding of automation systems used in the biopharma (Delta V, PLC, PI, etc.)
 Experience in working/leading within cross functional teams
 Experience with AutoCAD, Visio, MS Project, SuperPro
 Fluent in English and Mandarin both verbally and in writing

Desired Characteristics:
 Master’s Degree
 Disposable technology design and application experience
 2 years of direct working in facility design or operations in a cGMP facility
 Detail oriented, excellent at critical analysis and problem solving
 Experience working in global business environment with sound understanding of global processes
 Driven, clear thinking and an excellent communicator
 Structured, organized, Analytical, Team oriented

About Us:
GE (NYSE:GE) drives the world forward by tackling its biggest challenges. By combining world-class engineering with software and analytics, GE helps the world work more efficiently, reliably, and safely. GE people are global, diverse and dedicated, operating with the highest integrity and passion to fulfill GE’s mission and deliver for our customers. www.ge.com

Locations: China; ShangHai; Shanghai