MANUFACTURING ENGINEER- CLEANING

This role is dedicated to the overall cleaning process for all products made in Suzhou site, including IPC (In Process Clean) and Final Clean; 本岗位负责在苏州工厂所有产品的清洗工艺，包含过程清洗以及最终清洗； ▪ Lead and coordinate cleaning related activities cross Suzhou, sister sites, global Clean Virtual Team, and other global cleaning expert, ensure Suzhou cleaning technology comply to J&J standards and regulations.
主导和协调苏州和兄弟工厂，全球清洗虚拟团队以及其他全球清洗专家之间的项目，确保苏州 的清洗技术符合强生的标准以及法规要求； ▪ It covers the creation and maintenance of the required cleaning processes to assure the expected quality, on time delivery and cost efficiency.
涵盖创造和维护要求的清洗工艺满足预期质量，按时交付以及成本效率 ▪ Partner with cross functions to develop the quality system, validate equipment, processes, and products in order to guarantee full compliance with all regulations and quality standards.
与质量部门合作开发质量体系，验证设备，工艺确保符合法规和质量要求。 ▪ It also covers any other project as deemed necessary (H&S, Environment, etc…).
同时包含一些必要的其他项目（环境健康等相关） ▪ In collaboration with cross function team especially Sterility Assurance, develop and maintain all packaging and labeling processes for all products groups 和各部门尤其是无菌保证部门一起，开发 和维护所有产品的清洗工艺 ▪ Work with related functions in China and/or oversea, ensure in-time and compliant start-up of manufacturing at Suzhou site 和中国以及/或国外相关部门合作，确保苏州工厂启动项目的及时合 规性 ▪ Support to maintain the process routing, in the SAP system to make sure the product manufacturing process compliant with procedure requirement and validation result.支持维护SAP 中产品流程以确 保产品生产工艺符合流程要求以及验证结果。 ▪ Responsible for compiling all manufacturing procedures related with cleaning processes 负责编写所 有清洗相关的工艺文件 ▪ Deliver necessary training for shopfloor employees 给现场的员工做必要的培训 ▪ In collaboration with the maintenance team and calibration team, develop and implement Maintenance program and calibration activities.
和设备维护团队以及校准团队合作，开发和执行维护项目以及 完成校准行动项。 ▪ Propose, lead or participate in continuous improvement initiatives, such as projects to improve quality, cost, delivery and efficiency.
Predictively use methodology to improve processes and reduce non-value added waste and activities.
(Including process Risk Assessment Summary, use of statistical techniques 建议，领导或参与持续改善，例如一些提高质量和效率，降低成本的项目。前瞻性地使用一些 方法论提高工艺和降低没有附加值的浪费（包含pRAS 和一些数理统计的技术方法） ▪ Financial knowledgeable participate to identify capital spend and budget requirements 具备财务知 识，识别资本花费和预算需求 ▪ Support capacity planning/ management, identify needs of new equipment or processes.
Participate or lead the layout design / implementation for facility and equipment, can implement machine qualification and process validation 支持产能计划和管理，识别新设备或新工艺需求参与或指导 设备设施的布局涉及，能执行设备验证和工艺验证。 ▪ In partnership with the Quality department, participate to the development of the quality system and its day to day implementation 和质量部合作，参与开发质量体系确保日常执行 ▪ Understand the Quality philosophy based on FDA QSRs, ISO and CFDA requirements 理解基于 FSA QSRs, ISO 和中国食品药品监督管理局要求的质量方针 ▪ Understand, compile and control non-conformance data and product traceability 理解，符合，控制合 规以及产品的追溯性 ▪ Understand computer software validation requirements 理解计算机软件验证需求 ▪ Perform all job duties in full accordance with.
履行所有下述职责 - The J&J policies on Information, Assets protection, Maintain password(s) confidential, protect 强生 在信息技术，资产保护，密码的保密性 - Critical Business Information.关键业务信息 - All J&J policies and local regulations.
所有强生的政策和本地法规 - The policies of the Health Care and Environmental programs.
健康护理和环境程序政策 ▪ Propose, develop or participate in programs to improve H&S and Environment 建议，开发或参与项 目以提高环境健康 ▪ Full responsibility and ownership (like all employees on site) for all cleaning process related audits (internal, Corporate, External, for Quality, H&S, Environment, etc.) 负责所有清洗工艺相关的审核 （内部，公司层面，外部，质量，环境健康相关） Qualifications ▪ Chemistry experience / 化学相关经验 ▪ Cleaning process experience / 清洗过程经验 ▪ Project management 项目管理 ▪ Problem solving root cause analysis 问题解决根本原因分析 ▪ Good communication and presentation skill好的沟通和表达技能 ▪ Knowledge of lean production and six sigma精益生产和6西格玛知识 ▪ Team work spirit 团队合作精神