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更新于 1月21日

Lead Engineer, process (pharmaceutical)

2.8-4萬·13薪
  • 上海徐匯區(qū)
  • 10年以上
  • 碩士
  • 全職
  • 招1人

職位描述

工業(yè)建筑醫(yī)療建筑工業(yè)廠房E3DPDMS
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.
Additional responsibilities ? Knowledge of China and oversea GMP (NMPA, ISPE, ASME BPE, EP, USP) ? HAZOP Studies when required. ? Familiar with pharmaceutical system validation guidelines. ? Support DQ review and design GMP review. ? Other tasks assigned by Department manager
Professional experience & education ? Minimum of fifteen (15) years engineering experience and a minimum of ten (10) years in bioprocess design, preferably in the pharmaceutical and biotechnology industries. ? Experience in the life sciences (pharmaceutical, biotech, nutraceutical, etc.) is preferred. ? Sound knowledge of system design, applicable codes and cGMP’s as they affect process design and equipment specification and knowledge of pharmaceutical production ? Possesses a demonstrated ability for analytical thinking, an aptitude for structured problem solving, superior verbal and written communication skills as well as a strong work ethic. ? Must be able to build strong rapport within department and across Exyte disciplines. ? Travel may be required as projects are being executed at different parts of China. ? Knowledge of Good Manufacturing Practice (GMP) ? Knowledge of equipment design and system specifications, utility system calculations and energy optimizations ? Knowledge of installation, start-up and commissioning; handover of documentation activities ? Proficiency in spoken and written Chinse and English. ? Diligence to solve problems and finish the work in a structured manner ? Global mindset and enjoy working in a multi-cultural environment ? Result-oriented and have a well-structured approach to your work
Specific skills & knowledge ? Process design (Life Science) ? Process equipment (Life Science) ? Design criterial (GMP, ISPE, ASME, EP, USP) ? Process Calculation ? Process Layout ? Design software ? Validation ? Quality Assurance ? Regulatory Affairs

獎金績效

補助津貼

工作地點

上海市-徐匯區(qū)-龍文路317號

職位發(fā)布者

Amy Sun/HR

三日內(nèi)活躍
立即溝通
公司Logo益科德(上海)有限公司
About Exyte Exyte is a global leader in the design, engineering, and delivery of ultra-clean and sustainable facilities for high-tech industries. With cutting-edge expertise developed over more than a century, the company serves clients in the sophisticated markets of semiconductors, battery cells, pharmaceuticals, biotechnology, and data centers. Exyte offers a full range of services from consulting to managing the implementation of turnkey solutions with the highest standards in safety and quality to its customers worldwide. Exyte creates a better future by enabling key industries to enhance the quality of modern life. In 2023, the company generated sales of€7.1 billion with around 9,900 employees worldwide. Exyte提供卓越的設(shè)計、工程和施工服務(wù),是交付超潔凈和可持續(xù)高科技設(shè)施的全球先鋒。憑借一個多世紀(jì)里發(fā)展起來的尖端專業(yè)知識,Exyte活躍于全球市場,為半導(dǎo)體、電池、制藥、生物技術(shù)以及數(shù)據(jù)中心等對技術(shù)要求極高的客戶提供從前期咨詢到“交鑰匙”工程的全方位服務(wù),交付符合嚴格安全和質(zhì)量標(biāo)準(zhǔn)的設(shè)施。我們致力于助力高科技行業(yè)發(fā)展以提高現(xiàn)代生活質(zhì)量,從而創(chuàng)造一個更美好的未來。2023年,Exyte集團銷售額達到71億歐元,擁有約9,900名員工。 With the new year 2025, Exentec brings all aspects of the former Exyte Business Area Technology& Services under one cohesive brand identity. The purpose of Exentec is to provide the mission-critical technologies and services that our clients need for developing innovative product solutions that enhance the quality of modern life and create a better future.隨著新的2025年的到來,Exentec將前Exyte業(yè)務(wù)領(lǐng)域技術(shù)和服務(wù)的所有方面都整合到一個統(tǒng)一的品牌標(biāo)識下。Exentec的宗旨是提供客戶所需的關(guān)鍵任務(wù)技術(shù)和服務(wù),以開發(fā)創(chuàng)新的產(chǎn)品解決方案,從而提高現(xiàn)代生活質(zhì)量并創(chuàng)造更美好的未來。 www.exyte.net
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