Manufacturing Engineer - Cleaning

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:

Non-Standard

Job Sub Function:

Non-Employee

Job Category:

Non-Standard

All Job Posting Locations:

Suzhou, Jiangsu, China

Job Description:

• 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）