Shire Jobs

Manufacturing Engineer- Cleaning - 00001KT9

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）

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

Primary Location Asia Pacific-China-Jiangsu-Suzhou

Organization Johnson & Johnson Medical Suzhou Ltd. (7054)

Job Function Process Engineering

Req ID: 00001KT9