At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

工作部门Function:

QA-Environmental Monitoring

主要职能Key Responsibilities:

•        正确遵守HSE规程，在日常工作中正确穿戴PPE。

Apply HSE procedures correctly and correctly wear the expected PPE during work.

•        在日常工作中正确遵守数据完整性要求。

Apply Data Integrity requirement correctly during work.

•        正确遵守分级区的微生物和粒子监测的规程，执行环境监测取样操作，包括尘埃粒子监测，浮游菌，沉降菌和表面取样，以及人员监测。

Following the current procedures for microbiological and particle sampling of classified areas, and perform environmental monitoring sampling, including non-viable, viable, surface sampling and personnel monitoring.

•        正确遵守洁净系统监测规程，执行洁净系统质量监测，包括饮用水，纯化水，注射用水，洁净蒸汽和洁净压缩空气系统。

Following the current procedures for utility monitoring, and perform quality monitoring clean utility systems, including portable water system, purified water system, water for injection system, clean steam system and pharmaceutical compressed air system.

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•        安排当班工作和确认取样计划，确保监测项目，频率和取样操作取样符合流程要求。确保样品生命周期完整，周期性审核信息完整无误。

Arrange daily work and confirm sampling plan. Ensure monitoring items, frequency and sampling operations follow procedure requirements. Ensure sample life cycle complete and information complete and accurate based on periodic review.

•        作为日常取样操作的技术指导员，通过展示丰富的一线知识，遵守质量体系和使用正确的技术，起模范带头作用。

Work as technical instructor, setting a good example through demonstrating abundant shop floor knowledge, compliance with quality system and use of proper technique.

•        使用电子系统或纸质文件确保监测数据完整有效。

Using electronic system or paper documents, ensure complete and effective monitoring data.

•        确保所需物料和设备满足日常运营需求。需要协调解决日常运营中的物料和设备问题。

Maintain inventory of materials and equipment available for sampling needs. Coordinate the problem-solving for materials or equipment issues during routine work.

•        为环境监测和洁净系统监测提供技术支持，撰写和升版有关操作文件和资质认定文件，并提供培训。

Provide technical support for environmental monitoring and clean utilities. Write and manage revision of working instructions and qualification documents, and provide training.

•        参加环境监测性能确认。

Participate in Environmental Monitoring Performance Qualification (EMPQ)

•        协助无菌保证和EM/FUME不合格原因调查。

Assist root cause investigation of Sterility Assurance and EM/FUME non-conformances.

•        参加一线团队会议及相关工作，保持开放的沟通环境，加强团队合作，加强跨部门的员工合作和沟通。

Participate in zero loop meeting and related activities, maintain open communications and promote teamwork and employee participation and communicate in the work group with other departments

•        提供并审核批释放相关环境监控报告，提供环境监控数据和周期性趋势分析报告，便于工艺监控。

Create and review batch related environmental monitoring evaluation report. Share environmental monitoring data and write periodic trending analysis report for process monitoring.

•        开启和讨论发现项，为生产和公共设施团队执行维修活动提供环境监控的技术支持。

Originate and discuss observation. Provide EM technical input for production and utility related maintenance activities.

基本要求 Basic Requirements:

按时完成岗位相关的资质认定计划。
On time complete duty related personnel qualification programs.主管安排的其他任务Other jobs assigned by supervisor可参与倒班。Able to participate in shifts. 能够读懂、听懂英文可以进行简单书面和口头表达
Able to read and speak simple English 有英文写作能力和经验Have English writing capabilities and experience需要加班时要加班。工作需要的紧急情况需能够及时反应。
Ability to work overtime as required. Available off shift to respond to operational issues.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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