As the Lead Process Engineer, this role is responsible for
• Leading client discussions within process and facility design to assist the client to achieve their goals
• Feasibility studies up to detailed engineering
• Familiar with insulin Drug substance facilities design with specific emphasis in one or more of the following: upstream/downstream insulin processing, included media preparation, buffer preparation, Inoculum, seed expansion, fermentation producing, centrifugal separation, Harvest, purification process, CIP/SIP.
• Coordinates with project managers to determine project scope, complexity, and schedule for project development.
• Develops project execution plans (budget, milestones, deliverables and staffing plans) to deliver project on time, on budget and of the highest quality.
• Writes scope of work for process, utilities and manufacturing controls based on preliminary reviews with the client.
• Complete design deliverables for insulin process including, system schematic diagrams, BFD，PFD, mass balances calculation, black utility requirements and system P&IDs that include controls strategy, if appropriate.
• Process evaluation and optimization
• Development of URS, technical specifications, request for quotation, technical analysis and commercial evaluation of offers, follow-up of construction, pre-operational testing, installation commissioning and validation.
• Experience in design through qualification of stainless-steel fermenter, CIP/SIP unit, centrifugal unit, membrane filter unit, chromatography unit, ultra filter unit, freeze drying unit, fixed & mobile process vessels.
• Complete insulin process design for media preparation, buffer preparation, Inoculum, seed expansion, fermentation producing, centrifugal separation, Harvest, purification process, CIP/SIP.
• Familiar with upstream and downstream insulin process flow, personal flow, material flow and waste flow layout requirements
• Familiar with each of drug substance insulin process operation background and cleanness grade.
• Ensure completion of quality specifications and performance data sheets for process equipment and instrumentation.
• Make use of and participate in development of company design tools including process simulation and smart P&IDs (CAD, PDMS, Revit, plant 3D, Super pro, Schedule pro etc.).
• Establish and maintain excellent working relationships with clients and members of the Exyte design team.
• Collaboration in crossing-disciplinary teams
• Successfully interface with clients, project managers, and engineering professional and coordination between client and equipment suppliers.