KEY ACCOUNTIBILITIES:

• 领导新区DP3厂AIS团队，提供GMP IT 和自动化支持，满足DP业务和DI合规需求

• Lead DP3 AIS work stream to provide day to day support in GMP IT and Automation service, meeting business needs and DI compliance.

• 针对GMP关键设备和生产系统，从技术和合规层面管理计算化系统，提供服务如周期性回顾，数据管理，帐号管理。

• Manage computerized system in both technical and compliance aspects, supporting system periodical review, data management, user account management for GMP critical instrument and production skids.

• 提供PLC自动化专家支持，包括自动清洗，灌装，冻干及包装线。

• Provide PLC /automation support as in-house expert to automated line of drug product filling, lyophilization, and packaging.

• 作为GMP系统管理员或全球系统的就地管理员，支持实验室信息，质量管理等大型应用系统

• Act as administrator to local GMP IT system or site administrator of global system such as LIMS, Trackwise.

• 与AIS总部团队合作开展新项目，协调组织，收集分析需求，制定和执行项目计划

• Work with global AIS by collaborating with project sponsors and business stakeholders to define scope, analyze requirements, evaluate feasibility, and determine project implementation plan;

• 与IT， 工程团队，验证，质量，业务团队紧密合作，做好客户和监管部门的审计

• Coordinate and work with local IT, Engineering， CSQ, quality, validation, and business team to prepare system for regulatory and client inspection;

• 支持相关变更，偏差调查和整改, 起草文件

• Lead or support Change control, deviation and CAPA as system SME; prepare documentation work as needed

• 指导团队成员，发展和提升系统服务和数据分析能力

• Coach and guide team member, grow and improve system service and data analytical capability

REQUIREMENTS:

• Majored or trained in Automation, Electric engineering, Computer Science or related discipline is required with a minimum of 8 years of relevant experience in technical support, information or automation system operation, planning and deployment.

• Minimum of 4 years GMP experience with pharmaceutical manufacturing /PD/laboratory environment. Familiar with computerized system, Familiar with PLC (Siemens, Rockwell) based equipment skids, system setup, configuration and maintenance. Process knowledge in drug product (DP) production is a plus.

• Must have strong customer service, coordination and interpersonal skills

• Knowledge of regulatory requirements on computerized system and ERES, such as 21 CFR part 11

OTHER SKILLS, ABILITIES & EXPERIENCE:

• Excellent oral and written communication skills, leadership ability and ethical judgment

• Ability to work collaboratively within team and with other departments

• Ability to work effectively with minimal supervision

• Has CAN DO attitude to meet new challenge

上班地址：马山梅梁路108号

药明生物（股票代码：2269.HK）作为一家香港上市公司，是全球领先的开放式、一体化生物制药能力和技术赋能平台。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。截至2018年6月30日，在药明生物平台上研发的综合项目达187个，包括98个处于临床前研究阶段，78个在临床早期（I期，II期）阶段，10个在后期临床（III期）以及1个在商业化生产阶段。预计到2021年，公司在中国、爱尔兰、新加坡、美国规划的生物制药生产基地合计产能约22万升，这将有力确保公司通过健全强大的全球供应链网络为客户提供符合全球质量标准的生物药。如需更多信息，请访问：www.wuxibiologics.com.cn。
药明生物员工总数超过4000人，其中300多位是具有海外高等学位和工作经验的海归科学家，拥有欧美市场抗体开发、生产、质量控制、临床前研究和国际注册经验，高级管理层团队成员均工作在生物制药行业一线，并在各自专业领域平均拥有超过20年行业经验，打造了世界一流的生物药发现、开发及生产团队。