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Manufacturing Engineer- Cleaning
Location:
Suzhou
Description:
• 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 9000 and CFDA requirements 理解基于 FSA QSRs, ISO9000 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)• 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
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