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3-4年经验 -
本科 -
招若干人 -
12-19 发布
职位描述
Responsibilities to include hands-on involvement with the qualification and validation of GMP process equipment (Dispensing Device, Granulation Machinery, Encapsulation Filling Machinery, Tableting Machinery, Coating Machinery, Blister Packaging Machinery, etc.). Individual will be responsible for providing the qualification services of equipment and facility systems for our customers, planning and coordinating all the qualification related activities in our projects.Responsibilities will include:1. Develop the User Requirement Specifications (URS) for Facilities, Utility and Equipment (FUE) systems, and also for process control systems (e.g., DCS, SCADA) for customers.2. Develop the Qualification Project Plan (QPP) during the plan & design phase of our projects.3. Perform the SIA (System Impact Assessment) for the system in respect of its GMP impact.4. Perform the CA (Criticality Assessment) for the systems in respect of their criticality to product and data integrity.5. Create all the qualification plans and test protocols for system Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) in our projects.6. Coordinate all the qualification related activities, and prepare the qualification reports for our customer approval in our projects.The successful candidate will possess a BS degree or higher in chemical or mechanical engineering and must have a minimum of 5 years of hands-on process engineering experience in the pharmaceutical industry (preferably parenteral manufacturing). Technical knowledge regarding the design and operation of process equipment is required. Candidate must have demonstrated ability to solve technical problems and ability to work independently. Experience in equipment commissioning, qualification and validation programs is required. Solid experience with pharmaceutical manufacturing and support equipment is essential; working knowledge of process control systems (expertise with PLC hardware and SCADA computer systems) is required. Candidate must have excellent organizational, communication and personal work management and writing skills.Email：info@tagline-bas.com 职能类别： 专业顾问 生物工程/生物制药
联系方式
上海市浦东新区金湘路225弄11号
公司信息
上海塔戈楼宇位于浦东金桥开发区内。公司主要从事楼宇自控领域的技术开发、技术咨询和技术服务，并专注于制药、生物科学和医疗领域内的楼宇自动化系统的设计、销售、建设、调试和验证解决方案。 同时也是芬兰菲利克斯公司授权在华独家代理商；是维萨拉中国有限公司授权的生命科学工业CMS产品的系统集成商。公司专注于生物制药工程和洁净室项目的设计、验证和咨询等。本着用先进的建筑自动化设备/产品集成优越的系统，为广大客户提供更好更完善更先进的服务。现因公司业务发展需求，面向社会招聘，公司将提供良好的工作环境，五险一金，员工培训等。期待您的加入！
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