工艺工程师-制药

该职位来源于猎聘 As the process engineer, this role is responsible for

• Participate in engineering project teams to design aseptic and biotech processing facilities 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.
• Perform feasibility study, conceptual, basic, detailed designs and work package preparation for insulin projects.
• Drafting, Preparation of layout, BFD, PFD, PID, etc.
• Drafting annual production capacity and batch calculation
• Drafting production scheduling
• Drafting mass balance calculations
• Perform hydraulic, heat load, production planning, utilities calculation etc.
• Responsible for equipment package. Work with clients, vendor and other third parties to prepare datasheets, and specification.
• Multi-discipline, highly interactive team to establish process design basis, develop process options and optimizations of selected design, and calculate and organize data for process flow sheets
• Assesses compliance with applicable safety and environmental issues
• Support field construction efforts, including reviewing submittals, responding to questions from clients and contractors, and performing field walks.
• Support bio-pharma life science project in various phase such as support qualification work, C&Q (Commissioning and Qualification)
• Familiar with each of insulin process operation GMP requirement (operation background and cleanness grade).
• Perform technical and business presentations with clients and employees
• Capability of preparing URS/Specification and process layout, personal/material/equipment /waste flows
• Support validation team to prepare DQ/IQ/OQ protocols.
• Contributes to departmental efforts by accomplishing related tasks as needed.
• Accept project arrangements and business travel Professional experience & education
• Bachelor’s Degree : Chemical Engineering / Chemistry / Bio-medical Engineering
• Minimum 3 year experience in engineering company in pharmaceutical industry
• Experience using drawing tool such as CAD, Revit, Plant 3D, PDMS.
• Experience in develop layout, PFD, PID, specification, datasheet
• Experience in some basic engineering calculation, such as heat load calculation, hydraulic calculation, etc.
• Candidate with additional site experience and Qualification experience will have added advantage