Process Support Lead - CIP SIP 清洗灭菌

该职位来源于猎聘 必须： CIP, SIP, Clean Utiity, PCS7 英语口语流利 注意：所示薪资为预算参考值，实际offer将基于候选人资质和当前薪资灵活调整，可能高于或低于标注范围。

About The Job Ready to push the limits of what’s possible? Join Sanofi in one of our corporate functions and you can play a vital part in the performance of our entire business while helping to make an impact on millions around the world. As an Automation Utilities & process support for Insulin Factory Beijing (IFB) project within our Global Manufacturing Systems & Automation team, you’ll be part of Insulin automation’s team and report into an Automation Project lead. You will interface with different workstreams (Automation, CSV, CQV, Utilities, Process Engineering) and support the system integration management for upstream equipment and systems contained with the Drug Substance manufacturing aera of the facility. Main Responsibilities

• 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 Sanofi and 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

About You

• 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