Description
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:
QualityJob Sub Function:
Quality ControlJob Category:
ProfessionalAll Job Posting Locations:
Suzhou, Jiangsu, ChinaJob Description:
R&D
provide technical support on contamination control, biocompatibility and sterility assurance for new product development cycle. o apply best practices in the selection, investigation and validation of aseptic manufacturing and sterilization methodologies in accordance with applicable regulations and standards. o ensure design changes meet contamination control, biocompatibility and sterility assurance requirements. Form 103023725｜Rev D Page 2 of 5 Referenced Document Number: SCP-1001005 JD2023021 o support due diligence on contamination control and sterility assurance for acquisitions and new product licensing. o provide support in the development of design history files and regulatory submissions to ensure compliance to applicable regulations and standards internationally. o drive innovation to provide novel methodologies, processes or strategies for contamination control and sterilization. o provide expertise in the development of processing instructions for use and associated validation for the cleaning, disinfection and sterilization of non-sterile or reusable devices. ▪ 研发o 为新产品研发提供污染控制策略、生物相容性和无菌保证方面的技术支持，为产品整个研发周 期提供支持； o 依据适用法规和标准，运用良好规范进行无菌生产、生物相容性、灭菌方法的选择、调查和确 认； o 确保设计变更满足污染控制、生物相容性和无菌保证的要求； o 为产品注册提供污染控制和无菌保证方面的技术支持； o 为设计历史文档和法规注册提供支持，以确保符合适用的法规和标准要求； o 采用创新思维，为污染控制和灭菌策略提供新的方法学、过程和策略输入； o 为非无菌或可重复使用器械的清洁、消毒和灭菌的处理说明开发和相关确认提供技术支持；
▪ Plan
participate in the development and selection of new manufacturing operations (to include manufacturing sites and facility investments, contract sterilization & laboratories, and third-party manufacturers) ▪ 策划o 为新生产设施（包括生产地点、设施、委托灭菌、委托测试、委托生产）的开发和选择提供支 持；
▪ Source
Provide contamination control strategy support for sterile, non-sterile, biocompatibility or microbiologically controlled manufactured products; o provide technical support for procurement activities that relate to sterile, non-sterile, biocompatibility or microbiologically controlled products that are externally manufactured. o provide input in the design of new manufacturing processes, controlled environments and packaging from a microbiological, terminal sterilization, biocompatibility and reprocessing standpoint. o provide input for the design of Business Unit/Franchise critical water and air systems and the design of controlled environments and cleanliness control strategies. ▪ 采购o 为无菌、非无菌、生物安全性或控制微生物的产品提供污染控制策略的支持； o 为外部生产的无菌、非无菌、生物安全性或控制微生物的产品的采购提供技术支持； o 以微生物、终端灭菌、生物安全性和再处理的角度，为新生产过程、受控环境和包装的研发提 供输入； o 在供应商审计时，提供污染控制、生物安全性和无菌保证方面的技术支持； ▪ Makeo Coordinate the consistent implementation of contamination control, biocompatibility and sterility assurance, support document updates and cross-functional document integration in accordance with business unit, corporate documents and applicable international standards; o Master good practices, standards, and guidelines for sterilization, processing, aseptic technique, and environmental monitoring; o Support critical supplier management and facility audits, including as a point of contact for strategic collaboration; o Business continuity plan to support sterilization, biosafety and contamination control; provide technical leadership on contamination control and sterility assurance at Business Unit/Franchise manufacturing facilities.
▪ 生产
o 依据事业部、公司文件和适用的国际标准，协调污染控制、生物相容性和无菌保证的一致实 施，支持文件更新和跨事业部文件整合； o 掌握灭菌、加工、无菌技术和环境监控相关的良好规范、标准和指南； o 支持关键供应商管理和工厂审计，包括作为战略合作的联络点； o 支持灭菌、生物安全性和污染控制的业务连续性计划；
▪ Deliver
customer engagement and support, monitoring trends in Customer needs with feedback to Management. ▪ 交付o 参与和支持客户活动，监控趋势并向管理层反馈； ▪ External Influencingo identifies external opportunities to influence best practices in sterility assurance and contamination control by interacting with regulators, standard/guideline organizations, research and academic institutions. ▪ 外部影响o 监控无菌保证和污染控制相关的法规、规范并反馈给强生无菌保证委员会； ▪ Internal Influencingo interacts with business leaders to ensure objectives and project prioritization meet business needs. Interacts with their peers in sterility assurance to utilize resources and ensure best practices across facilities. o participate on the J&J Microbiological Quality & Sterility Assurance councils o Performing other related duties as assigned by management. ▪ 内部影响o 与污染控制策略主管沟通，确保目标和项目优先级满足业务需要，与无菌保证同事沟通，利用 资源确保良好规范得以实施。 o 参加强生无菌保证委员会。 o 执行管理层安排的其他相关的职责。
This job is mainly focusing on lab operation and routine test to support SA validation. It's a WAGE position.
该岗位主要专注实验室运营和日常测试以支持SA验证为主。是一个WAGE岗位。
