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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.
The enterprise solutions organization is looking for a Process Design Engineer to lead the process design for FlexFactory manufacturing, ensuring compliance with the applicable regulatory requirements; optimized performance for the customer's process, operation, facility layout and regional location.
The Process Design Engineer will be responsible for providing competence and technical leadership in process, equipment and facility design related to biopharmaceutical manufacturing. The Process Design Engineer will lead the process design efforts to ensure optimal outcomes to support the customer application and manufacturing operation, in compliance with the applicable regulatory requirements. The Process Design Engineer will provide the necessary technical input to support/enable the design and development of biopharmaceutical manufacturing suite layouts, process equipment design, process equipment layout, clean utility requirements, and overall process engineering oversight required to ensure fit and function for the manufacturing technology application in alignment with customer needs and regulatory requirements.
• Support customer meetings by providing process understanding from pilot scale operation, technology transfer, large scale manufacturing and facility design experience. Develop, explore and recommend manufacturing concepts to fit customer needs/facility requirements.
• Provide Process Design & Engineering leadership to the Enterprise Project Team.
• Work closely with the Enterprise Solutions Project Manager to support the Enterprise Solutions project specific design development, documentation and execution in alignment with the project scope and schedule.
• Work closely with Customer's Subject Matter Experts (SMEs) to ensure continuous exchange of critical and technical information needed to execute design activities in support of the project timeline.
• Work closely with Engineering partner companies during Conceptual and Basic design development to ensure suitability, applicability and accuracy of Engineering partner designs, calculations, drawings; ensure they are in alignment with customer requirements.
• Prepare design documentation and operational estimates such as Process Descriptions, Process Flow Diagrams (PFDs), Equipment Lists, Equipment and Automation URSs, Process Schedules, Production Planning, and utility usage estimates, Risk Assessments, Materials Balances, Cost of Goods Analysis, Cycle Time Analysis and Reduction, Uncertainty and Variability Analysis.
• Work closely with FlexFactory Lead System Designers (LSDs) to ensure transfer of critical equipment requirement specification, that design meets customer and process needs, and that single-use equipment layout is optimized for the customer facility.
• Provide design input, support and recommendations as needed with qualification test review and verification and during field execution, commissioning and qualification testing.
• Approximately 10-30% travel depending on project specifics and geographic location.
• BS degree in biochemical / chemical engineering or a related engineering/life Science discipline
• Minimum of 5 years of relevant bioprocess experience.
• Experience in process development, tech transfer, scale-up and operation of biopharma facilities
• Experience in process modeling
• Knowledgeable in all aspects of upstream and downstream processes including batch, fed-batch and perfusion cultures; harvest/clarification; Chromatography and UF/DF operations
• Experience in clinical manufacturing of monoclonal antibodies and other biologics
• 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
• Fluent in English both verbally and in writing
• Comfortable in giving conference presentations and writing technical articles
• Experience in AutoCAD, Visio, MS Project SuperPro applications
• Master's Degree
• Minimum of 2 years of direct experience working in a pilot plant or GMP manufacturing facility
• Disposable technology design and application experience
• Detail oriented, excellent at critical analysis and problem solving
• Experience working in global business environment with sound understanding of global processes.
• Open to a changing environment
• Structured, organized, Analytical, Team oriented
Locations: United States; Massachusetts; Marlborough
GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer at http://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditional upon the successful completion of a background investigation and drug screen.
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