Senior Sterilization Engineer（高级灭菌工程师
强生(苏州)医疗器材有限公司
- 公司性质：外资(欧美)
- 公司行业：医疗设备/器械
职位信息
- 发布日期：2017-04-09
- 工作地点：苏州
- 招聘人数：1人
- 工作经验：3-4年经验
- 学历要求：本科
- 语言要求：英语 熟练
- 职位月薪：0.8-1.3万/月
- 职位类别：其他
职位描述
职位描述：
岗位职责：
SCOPE OF THE ROLE AND BASIC PURPOSE/职位与基本目的的范围
§ Provide project management for installation and start-up of primary EO cycle sterilization and vacuum drying equipment for absorbable sutures
§ Provide direct engineering support to the regular production sterilization processing lines in Suzhou, P.R.China and Aurangabad, India
§ Ensure that the sterilization processing equipment is maintained as required by the manufacturer and applicable internal J&J policies/procedures
§ Ensure that the sterilization process complies with its specifications and is capable of consistently meeting the applicable specification requirements.
§ Conduct sterilization equipment and process calibration, IQ / OQ / PQ, and applicable revalidations/requalifications.
§ Conduct cleaning / sterilization validations of terminally sterilized medical devices using Gamma irradiation / EO.
§ In partnership with campus microbiologist, provide the necessary sterilization information (processing requirements, applicable quality system procedures/work instructions, equipment manuals, and etc.) for the implementation and validation of the microbial aspect for all related upstream and downstream equipment and processes.
KEY RESPONSIBILITIES/TASKS (indicate estimated % of time spent where possible)/ 主要职责/任务 (以时间的百分比表示)
1. 60% - Engineering
2. 20% - Quality
3. 10% - Facility & EHS
4. 10% - Others
ACCOUNTABILITIES/KEY MEASURES/职责/主要衡量指标
§ Responsible for leading projects for installing and starting up primary cycle sterilization, vacuum drying, and associated ancillary equipment
§ Responsible for leading the qualification and validation/re-validation of external Gamma irradiation / internal EO sterilization process.
§ Responsible for leading the sterilization validations of terminally sterilized medical devices
§ Responsible for providing technical expertise and leadership for daily manufacturing operations and ensuring established metrics (Production, Quality, Scrap and Cycle Time) are met.
§ In partnership with campus microbiologist, responsible for the necessary information for implementation and validation of the microbial aspect for all related equipment and processes.
§ Utilizes Process Excellence methodology and tools to identify and implement improvement projects geared to reduce cost, eliminate scrap, improve quality and minimize cycle time.
§ Establishes specific manufacturing capability technology to support transfers and new product introduction.
§ Provides specific technical expertise to support special projects, pilot operations, product and process improvements; and also provides input to develop capital expense forecast and equipment/spare parts budgets to support business needs.
§ Identifies and develops corrective action plans to improve instruments reliability in the field.
§ Provides support to product inquiry investigations.
§ Follow all company safety policies and other safety precautions within the work area.
§ Supports supplier evaluations for major services/products as needed.
§ Compliance with safety policies and procedures.
§ Ensures compliance with Environmental Management System (EMS) responsibilities.
§ Follow J&J and EES Records Management Policies for Convenience Information, Records Retention Schedules, Training and Education, Document Hold Notices, Records Cleanout, Inactive Records and Information Management, Vital Records and third party vendor if applicable.
§ Other responsibilities may be assigned and not all responsibilities listed may be assigned.
§ Provides and implements robust corrective actions to quality, safety and ergonomic risk detected in the manufacturing area.
§ This position travels occasionally.
任职要求：
Type of Experience/经验类型:
§ Production engineering in Medical industry.
Required Competencies and Skills/所需的能力与技能:
§ Bachelor of Science in Engineering or other technical discipline.
§ Three to five years’ experience of Gamma irradiation / EO sterilization process is preferred
§ Fluent in English is preferred.
§ GMP/ ISO knowledge is preferred.
§ Knowledge of product and process design and development, materials, standardization science and applied statistics.
§ Knowledge of project management and cost analysis is preferred.
§ Knowledge of word processing, spreadsheet analysis, data management, projects management, presentation graphics, engineering analysis and statistical software.
§ Knowledge of information systems including but not limited to Enterprise Resource Planning (ERP), CAF, Quality Systems and Documentation Control Systems..
§ Advance technical training in area(s) of expertise is preferred.
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岗位职责：
SCOPE OF THE ROLE AND BASIC PURPOSE/职位与基本目的的范围
§ Provide project management for installation and start-up of primary EO cycle sterilization and vacuum drying equipment for absorbable sutures
§ Provide direct engineering support to the regular production sterilization processing lines in Suzhou, P.R.China and Aurangabad, India
§ Ensure that the sterilization processing equipment is maintained as required by the manufacturer and applicable internal J&J policies/procedures
§ Ensure that the sterilization process complies with its specifications and is capable of consistently meeting the applicable specification requirements.
§ Conduct sterilization equipment and process calibration, IQ / OQ / PQ, and applicable revalidations/requalifications.
§ Conduct cleaning / sterilization validations of terminally sterilized medical devices using Gamma irradiation / EO.
§ In partnership with campus microbiologist, provide the necessary sterilization information (processing requirements, applicable quality system procedures/work instructions, equipment manuals, and etc.) for the implementation and validation of the microbial aspect for all related upstream and downstream equipment and processes.
KEY RESPONSIBILITIES/TASKS (indicate estimated % of time spent where possible)/ 主要职责/任务 (以时间的百分比表示)
1. 60% - Engineering
2. 20% - Quality
3. 10% - Facility & EHS
4. 10% - Others
ACCOUNTABILITIES/KEY MEASURES/职责/主要衡量指标
§ Responsible for leading projects for installing and starting up primary cycle sterilization, vacuum drying, and associated ancillary equipment
§ Responsible for leading the qualification and validation/re-validation of external Gamma irradiation / internal EO sterilization process.
§ Responsible for leading the sterilization validations of terminally sterilized medical devices
§ Responsible for providing technical expertise and leadership for daily manufacturing operations and ensuring established metrics (Production, Quality, Scrap and Cycle Time) are met.
§ In partnership with campus microbiologist, responsible for the necessary information for implementation and validation of the microbial aspect for all related equipment and processes.
§ Utilizes Process Excellence methodology and tools to identify and implement improvement projects geared to reduce cost, eliminate scrap, improve quality and minimize cycle time.
§ Establishes specific manufacturing capability technology to support transfers and new product introduction.
§ Provides specific technical expertise to support special projects, pilot operations, product and process improvements; and also provides input to develop capital expense forecast and equipment/spare parts budgets to support business needs.
§ Identifies and develops corrective action plans to improve instruments reliability in the field.
§ Provides support to product inquiry investigations.
§ Follow all company safety policies and other safety precautions within the work area.
§ Supports supplier evaluations for major services/products as needed.
§ Compliance with safety policies and procedures.
§ Ensures compliance with Environmental Management System (EMS) responsibilities.
§ Follow J&J and EES Records Management Policies for Convenience Information, Records Retention Schedules, Training and Education, Document Hold Notices, Records Cleanout, Inactive Records and Information Management, Vital Records and third party vendor if applicable.
§ Other responsibilities may be assigned and not all responsibilities listed may be assigned.
§ Provides and implements robust corrective actions to quality, safety and ergonomic risk detected in the manufacturing area.
§ This position travels occasionally.
任职要求：
Type of Experience/经验类型:
§ Production engineering in Medical industry.
Required Competencies and Skills/所需的能力与技能:
§ Bachelor of Science in Engineering or other technical discipline.
§ Three to five years’ experience of Gamma irradiation / EO sterilization process is preferred
§ Fluent in English is preferred.
§ GMP/ ISO knowledge is preferred.
§ Knowledge of product and process design and development, materials, standardization science and applied statistics.
§ Knowledge of project management and cost analysis is preferred.
§ Knowledge of word processing, spreadsheet analysis, data management, projects management, presentation graphics, engineering analysis and statistical software.
§ Knowledge of information systems including but not limited to Enterprise Resource Planning (ERP), CAF, Quality Systems and Documentation Control Systems..
§ Advance technical training in area(s) of expertise is preferred.
职能类别： 其他
公司介绍
强生（苏州）医疗器材有限公司诚聘
联系方式
- Email：jjmszl@its.jnj.com
- 公司地址：地址：span上海