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General Electric Company

Project Engineer

General Electric Company - Plano, TX

**About Us:**

GE is the world's Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. Through our people, leadership development, services, technology and scale, GE delivers better outcomes for global customers by speaking the language of industry.

**Role Summary:**

The enterprise solutions organization is an initiative within GE Life Sciences that focus on establishing biopharmaceutical manufacturing capacity for customers. By leveraging on the business units extensive product portfolio and process know-how the aim is to sell projects to customers who wants to set up their own manufacturing plant.

**Essential Responsibilities:**

The enterprise solutions organization is looking for a Project Engineer (PE) to 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 customers process, operation, facility layout and regional location.

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.

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.

Duties include:

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 Customers 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:**

Masters 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

**Locations:** Malaysia, Singapore; Singapore, Kuala Lumpur

7 days 18 hours ago

General Electric Company

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Project Engineer General Electric Company - Plano, TX, United States

   

Location: Plano, TX

Company Profile:
GE {NYSE: GE} works on things that matter. The best people and the best technologies taking on the toughest challenges. Finding solutions in energy, health and home, transportation and finance. Building, powering, moving and curing the world. Not just imagining. Doing. GE works.