MQ&SA Senior Scientist
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Job Location:
Monthly Salary:
Posted on:
3 days ago
Vacancies:
1 Vacancy
Job Summary
At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .
As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
Non-StandardJob Sub Function:
Non-EmployeeJob Category:
Non-StandardAll Job Posting Locations:
Suzhou Jiangsu ChinaJob 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AAMIISOAORN)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:
Required Experience:
Senior IC
Key Skills
- Laboratory Experience
- Mammalian Cell Culture
- Biochemistry
- Assays
- Protein Purification
- Research Experience
- Next Generation Sequencing
- Research & Development
- cGMP
- Cell Culture
- Molecular Biology
- Flow Cytometry
About Company
About Johnson & Johnson A t Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s larges ... View more
