Manufacturing Engineer - Cleaning

Johnson & Johnson Johnson & Johnson · Pharma · Suzhou, Jiangsu, China

Manufacturing Engineer role focused on developing and maintaining packaging, labeling, and cleaning processes for products at the Suzhou site. Responsibilities include process validation, training, continuous improvement initiatives, capacity planning, and ensuring compliance with quality and regulatory standards (FDA QSRs, ISO 9000, CFDA).

What you'd actually do

  1. 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
  2. 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
  3. 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。
  4. 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
  5. Deliver necessary training for shopfloor employees给现场的员工做必要的培训

Skills

Required

  • process development
  • process validation
  • quality systems
  • SAP
  • regulatory compliance
  • continuous improvement methodologies
  • training delivery
  • maintenance program development
  • calibration activities
  • capacity planning
  • facility and equipment layout design
  • machine qualification
  • non-conformance data control
  • product traceability
  • computer software validation
  • H&S and Environment programs

Nice to have

  • financial knowledge
  • statistical techniques