MQ&SA Scientist

Auris Health

Auris Health

Suzhou, Jiangsu, China
Posted on Tuesday, September 12, 2023


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。


§ Qualified candidates will have experience in microbiology, sterilization validation (terminal, aseptic, and/or reprocessing) and environmental controls for a medical device or pharmaceutical manufacturing facility.合格的候选人将具有微生物学、灭菌验证(终端、无菌和/或再处理)和医疗设备或制药设备的环境控制方面的经验。

§ Demonstrated competency in terminal sterilization, Reprocessing, and microbiological contamination is required.需要具备终端灭菌、再处理和微生物污染方面的能力。

§ Demonstrated competency in multiple healthcare and industrial terminal sterilization methods (e.g., EO, gamma, electron beam, moist heat, dry heat) is required.需要具备多种医疗和工业终端灭菌方法(如EO、gamma、电子束、湿热、干热)的能力。

§ In a supervisory, coaching, mentoring and/or influencing capacity is required.需要具备在监督、培训、指导和/或影响的能力。

§ Experience in interacting with Auditing Bodies (e.g. FDA, EU, etc) is preferred.有与审计机构(如FDA, EU等)沟通的经验者优先。

§ Proven track record on monitoring and troubleshooting process non-conformances and out of specification test results and providing resolution to issues by a robust CAPA process across multiple regions. 对不符合和超出规格的测试结果的监控和调查方面有可靠的跟踪记录,并能通过稳健的CAPA过程为跨多个区域的过程来提供解决方案。

§ Experience with conducting technical assessments of in-house and external manufacturing and terminal sterilization is preferred. 有内部和外部制造和终端灭菌的技术评估经验者优先。

§ Proven track record on trouble shooting microbiological, aseptic processing and/or sterilization process non-conformances and out of specification test results and providing resolution to issues via a robust CAPA process is required. 有解决微生物问题、无菌处理和/或灭菌过程不合格和不合格测试结果有可靠的跟踪记录,并通过稳健的CAPA流程解决问题。

§ Strong knowledge of standards including EU, USA and ISO is required. 熟悉欧盟、美国和ISO标准。

§ Excellent oral and written skills and able to communicate both up and down the business ladder within franchise or technical competency area is required. 优秀的口头和书面表达能力,能够在特许经营或技术能力领域内沟通。

§ Demonstrated ability to work in a collaborative/teamwork environment is required. 需要有在协作/团队合作环境中工作的能力。

§ Independent organizational and time management skills is required. 需要独立的组织和时间管理技能。

§ Team player with a customer focus is required. 需要有团队合作精神,以客户为中心。