JD基本信息
岗位职责
• Control of project processes or ensure project implementation in accordance with customer orders in terms of costs, deadlines, quality and resources. Coordinate project progress with the project team, operators, and supervisors. Initiating and monitoring corrective actions in the case of target deviations
• Lead the design and development of control systems for Insulin manufacturing utilities, esp. clean utilities and processes, ensuring accurate installation and compliance with safety and sustainability objectives
• Integrate automation systems with digital applications, ensuring seamless connectivity between production, quality control, and data management
• Act as a subject matter expert in the concept, design, fabrication, commissioning, and qualification of automation systems in a GMP-compliant biopharmaceutical environment for utilities and support processes
• Provide clear documentation for delivered solutions and processes; work closely with QA partners while supporting computerized systems validation processes in a GxP environment. Maintain Data Integrity Assessments with the current Industry standards
• Build the business processes to support the project scope in alignment with project timelines
• Support commissioning and qualification efforts including Automation Installation Verification/Automation Check Out (IV/ACO) in a fast-paced environment
任职要求
Experience: Experience in Capital Project Lifecycle Management: Conceptual Design, Scope and cost estimate development, case development, detailed design, engineering and validation documentation and project execution; Direct knowledge of Automation System design, experience in Process control engineering and troubleshooting with GMP biopharmaceutical production facility equipment/systems automation such as media, harvest, bioreactors and integrating various OEM automation software
Soft and technical skills: Extensive understanding and background in programming, design, installation and lifecycle management of manufacturing process controls, automation and field instrumentation technologies; Strong leadership, technical writing, and communication/presentation skills
Education: A master's degree in Engineering, Automation, Computer Science, Biotechnology, Pharmaceutical Sciences, or equivalent job certificate/education
Languages: Proficiency in English and Chinese is essential; German language skills are a plus
工作城市:
北京,招聘1人,详细地址:北京市北京经济技术开发区兴盛街7号