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Job Function:

Non-Standard

Job Sub Function:

Non-Employee

Job Category:

Non-Standard

All Job Posting Locations:

Suzhou, Jiangsu, China

Job Description:

The Senior Scientist is responsible for principle duties: 高级研究员主要职责: R&D 研发– Provide input for the following for increasing complexity projects: 为以下日益复杂的项目提
供输入：

• Design for cleanability 可清洁性的设计

• Design for decontamination 除污设计

• Design for sterilizability 可灭菌性设计

• Drive selection of sterilization modality, validation approaches and validation of the sterilization
  process. 驱动灭菌方式的选择、验证方法和灭菌过程的验证。

• Generate sterilization product adoptions .灭菌产品的采用。

• Support the regulatory approval of sterile and non-sterile new products, including internal research &
  development products, new acquisitions, and strategic partnerships.支持无菌和非无菌新产品的监管
  批准，包括内部研发产品、新收购和战略合作伙伴关系。

• Support the implementation of new innovations in the areas of contamination control, terminal
  sterilization, and reprocessing, to include such activities as i participating in development of new
  products.支持在污染控制、终端灭菌和再处理等领域实施新的创新，包括参与新产品开发等活
  动。

• Plan 计划 –

• Provide input into the selection of new manufacturing operations (to include manufacturing sites and
  facility investments, contract sterilization & laboratories, and third-party manufacturers).为选择新的生
  产运营提供输入(包括生产场地和设施投资，合同灭菌和实验室，以及第三方制造商)。

• Source 采购–

• Provide sterility assurance and contamination control support for due diligence for sterile, non-sterile or
  microbiologically controlled manufactured products, and provide technical SME support for integration
  into J&J.为无菌、非无菌或有微生物控制要求的产品的尽职调查提供无菌保证和污染控制支持，
  并为强生并购提供专业技术支持。

• Provide sterility assurance and contamination control for procurement activities that relate to sterile,
  non-sterile or microbiologically controlled products that are externally manufactured.为与外部生产的
  无菌、非无菌或有微生物控制要求的产品相关的采购活动提供无菌保证和污染控制。

• Provide input in the design of new manufacturing processes, controlled environments and packaging
  from a microbiological, terminal sterilization and reprocessing standpoint.从微生物学、终端灭菌和
  再处理的角度，为新生产工艺、受控环境和包装的设计提供输入。

• Provide input for the design of critical water and air systems and the design of controlled environments
  and cleanliness control strategies.为关键水和空气净化系统的设计以及受控环境和清洁控制策略的
  设计提供输入。

• Provide sterility assurance and contamination control support for supplier audits.为供应商审核提供无
  菌保证和污染控制支持。

• Make制造 –

• Provide sterility assurance and contamination control support to strategic MAKE initiatives.为战略计
  划提供无菌保证和污染控制支持。

• Provide input into process risk assessments related to product cleanliness and sterility assurance.为与产
  品清洁和无菌保证相关的过程风险评估提供输入。

• Lead non-conformance/CAPA pertaining to product cleanliness and sterility assurance .主导产品清洁
  和无菌保证相关的NC/CAPA。

• Work with internal and external laboratories to support sterility assurance testing requirements. Assure
  implementation of laboratory testing requirements for cleanliness and sterility assurance. 与内部和外
  部实验室合作，支持无菌保证测试要求。确保执行清洁和无菌保证的实验室测试要求。

• Provide support to internal and external audits. 为内部和外部审计提供支持。

• Deliver 交付–

• Support the ongoing initiatives regarding the validation and improvement of primary non-sterile and
  sterile packaging systems that meet the needs of distribution system and delivery of sterile or
  microbiologically controlled product to the patient and/or consumer. 支持进行中的验证和改进非无菌
  和无菌初包装系统的活动，以满足配送系统的需求，并向患者和/或消费者交付无菌或有微生物
  控制要求的产品。

• External Influencing 外部影响 –

• Provide site input to the J&J representatives of industry and standards associations (e.g., AAMI, ISO,
  AORN), influencing regulations and standards. 为行业和标准协会(如AAMI、ISO、AORN)的代表
  提供输入，以影响法规和标准。

• Internal Influencing 内部影响–

• Participate on the J&J Sterility Assurance Councils.参加强生无菌保证委员会。

Required Skills:

Preferred Skills: