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无工作经验 -
招若干人 -
12-28 发布
职位描述
KEY ACCOUNTIBILITIES:1. As subject matter expert in automation, instrumentation and electrics to support WuXi Bio’s clinical commercial manufacturing for biologics drug substance and product.2. Provide facility and process automation strategy, technical review, network design, system specification, and project management.3. Lead Bioreactor control system (TruBio or like) project from URS to qualification to commissioning; implement maintenance program to support bioreactor operation.4. Support plant operation including account maintenance, system configuration per MBR, troubleshooting, deviation and root cause analysis.5. Implement SOPs for system operation, data backup and security, disaster recovery, configuration management to satisfy the requirement for GMP compliance and data integrity.6. Prepares /creates necessary documentation, SOP, deviation report for all stage activities.7. Conducts system health and, opportunity assessment and continuous improvements.8. Works closely with manufacturing and quality team to provide day-to-day support, including troubleshooting, data retrieving, printing reports, alarm response and escalation.REQUIREMENTS:1. Bachelor’s degree in Electrical, Computer or Chemical Engineering with a minimum of 7 years of relevant experience in automation2. Prior experience of working in biologics /chemical process and manufacturing; GMP experience is a plus.3. Proven experience of operating deltaV automation system; familiar with iFix graphics, deltaV architecture and software, familiar with historian and alarm management.4. Knowledge of bioreactor process and its basic control principle.5. Excellent oral and written communication skills, leadership ability and ethical judgment.6. Ability to work collaboratively within team and with other departments.7. Ability to work effectively with minimal supervision.8. Has CAN DO attitude to meet new challenge. 职能类别: 生物工程/生物制药
联系方式
上海市外高桥保税区富特中路288号
公司信息
药明生物(WuXi Biologics)是香港上市公司(代码:2269),我们是全球领先的开放式、一体化生物制药能力和技术平台,旗下包括无锡药明康德生物技术股份有限公司、上海药明生物技术有限公司、苏州药明康德检测检验有限责任公司,并在美国和英国设有子公司。公司为全球生物制药公司和生物技术公司提供全方位的端到端研发服务,帮助任何人、任何公司发现、开发及生产生物药,实现从概念到商业化生产的全过程,加速全球生物药研发进程,降低研发成本,造福病患。目前,公司规模达到2300多人,有200多位拥有海外高等学位和工作经验的海归科学家,拥有丰富的欧美市场抗体开发、生产、质量控制、临床前研究和注册的经验,打造了世界一流的生物药研究、开发及生产团队。 更多信息,请登录公司官网:http://www.wuxibiologics.com.cn/
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