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