诺和诺德（中国）制药有限公司天津生产厂是诺和诺德全球唯一的胰岛素耐用注射器械供应商，以及重要的胰岛素制剂与灌装生产基地，在2019年，2020年及2022年荣获Kincentric“最佳雇主”称号。

Education Background: 教育背景

• Bachelor Degree major in water treatment, chemical engineering, pharmaceutical or other relevant fields. 水处理、化工工程、制药工程或相关专业领域大学本科毕业。
• Excellent communication skill in written and spoken English. 熟练的英语听说读写技能。

Professional Experience专业经验:

• Minim 5 years of experience in pharmaceutical manufacturing with cGMP regulation. 至少5年制药加工行业相关工作经验，熟悉cGMP规范。
• Engineering experience in water treatment systems or other aseptic utilities system maintenance, operation, process improvement and root cause analysis. 具备水处理或其他洁净公用工程相关的运行、维护、工艺改进以及故障根本原因分析等技术工程类经验。
• Proven expertise in execution of validation and GMP relevant documentation (NC/CR/QAP) etc. Following up on the process and relevant stakeholder, and revising the work plan for complex problems being resolved by cross functional teams on time. 具备验证和GMP相关文件等的处理能力，并且具有应急复杂问题分析处理能力以及跨部门协作沟通解决问题能力。
• Have knowledge in the following systems: mechanical, pharmaceutical utility, process design and project management etc. 具有机械工程、制药公用工程、系统设计和项目管理等的专业知识背景。

Key areas of responsibility 主要工作职责:

CU engineer is responsible for ensuring utility stable supply to aseptic production area with high efficiency and high quality and expected time. Work according to cGMP/GMP requirement, ensure continuous improvement. 洁净设施工程师的职责是保证洁净设施系统运行稳定，高效、高质量以及及时地供应无菌生产区域。遵循cGMP 、GMP要求执行工作，确保持续改进。

Main Job Tasks 主要工作任务:

• Lead and perform clean utility operation and maintenance work. 带领并执行洁净设施系统运行和维护工作：

O Daily operate clean utility system (CPW, WFI, clean steam system, process air) and do process confirmation. Guarantee all systems are in safety, stable, high-efficiency running status. 日常运行洁净设施系统， 并对系统进行日常过程确认，确保所有系统在安全、稳定、高效的运行状态。

O Prepare and execute clean utility system PM plan for fast action in emergency maintenance activities and right execution in PM activities timely, be proficient in SAP PM and MM for routine maintenance and spare part management. 正确制定预防性维修计划，准确及时执行预防性维护以及应急维修，熟练使用SAP系统进行维修以及备件管理。

O Establish and improve CU systems maintenance standards, processes/procedures and system to meet GMP requirement. 建立和改进洁净设施系统维护标准、工作流程和程序等。

O Prepare and execute CU systems validation activities and handle GMP relevant document work. 执行系统验证活动，完成相关文件处理工作。

O Lead on the difficult problem solving on systems maintenance. Actively initiate continued improve black utility systems to meet the requirement of system stable, safe and high-efficiency running. Cause analysis and PM/CM action setting up by LEAN thinking and tools. 带领解决系统维护的复杂问题。主动实施系统的持续改进，将精益生产的工具和理念应用到预防性维护、日常维修以及故障根本原因分析中。

O Train CU technician about complex and important maintenance task. Coach CU technician on maintenance skill development and problem solving. 培训并指导技术员，提高技能以完成复杂的维护工作任务和解决问题。

O Support system maintenance activities during shut down period, and support improvement for the planning of maintenance activities.支持大修期间的维护活动，支持维护活动计划及工作安排的优化。

• Lead, manage and participate CU projects. 带领、管理以及参与洁净设施项目执行：

O Lead and manage CU owned projects including facility owned system improvement project, GxP related critical system validation and re-validation project, etc. 带领和管理洁净设施部门项目，包括系统改进项目、GxP相关重要系统验证及再验证项目等。

O Support on other area projects as CU packager owned, take the responsibility for input on CU related system and ensuring quality. 作为洁净设施业务负责人参与其他部门的项目，提出建议和意见，确保项目质量。

O Support or lead water and energy saving project driving. 支持或主导节水，节能项目的实施。

O Drive CU process improvement project to support system smooth running, reduce OOS/alarm/CM 支持系统改进支持系统稳定运营，支持0 OOS，降低alarm，减少CM

•Take the responsibility of quality control within clean utility area: 负责质量控制工作：

O Prepare and ensure readiness for audit and inspection. During audit and inspection, present own process, guide audit tour on shopfloor, answer questions. Coordinate with department to fulfil audit and inspect request. 准备并应对审计和检查：在审计期间介绍工作流程、带领审计官巡视现场、回答问题。与相关部门合作完成审计和检查提出的要求。

O Ensure compliance of CU processes as well as product quality of water 作为系统专家，确保系统的符合性及水的质量。

O Ensure global SOP and GMP requirements implementation.确保标准操作流程（SOP）和GMP要求实施。

O Train other engineers on process knowledge, coach on compliance. Identify compliance gaps in responsible process. Share findings and new regulation requirement.向其他工程师提供工艺知识和合规的培训；发现合规风险，分享发现的问题和新的规定。

O Review NC/CR, give inputs, finish all related actions on time. 审核偏差和变动事件，给出意见和建议，按时完成相关行动计划。

O Drive for continually improvement. Coordinate with SME group to drive sharing knowledge and alignment of process. Share best practice across site.推动持续改进，与过程专家小组合作统一工艺流程标准、分享知识和最佳实践。

•Responsible for supervise the 3rd party suppliers working on facility maintenance work and project. Ensure the 3rd party suppliers perform the work by strictly following the procedure and standard of NN.负责管理第三方供应商的厂务维护工作和项目工作，确保第三方供应商在严格遵守诺和诺德流程和标准的前提下实施工作。

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.