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Lilly TS/MS Engineer - SA in Suzhou Manufacturing-苏州, China

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 39,000 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.

TS/MS Engineer - SA

作为SA & Validation Joint角色,同时支持SA和Validation相关的工作:

制作、审查、批准文件,对相关技术文件如:变更控制,法规文件,偏差调查,验证方案和验证报告,标准操作规程,工艺流程文件和验证总计划的准备提供技术支持。

Prepare, review, approve and provide technical support for preparation of relevant technical documents, as required, such as: change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, procedures, PFDs, and VMPs.

从风险角度考虑,评估现有的无菌产品生产工艺及对相关潜在的微生物,内毒素和微粒子的污染的控制, 包括但不限于:

Use of risk-based approaches to evaluate existing parenteral products manufacturing processes and associated controls with respect to the potential for introduction of microbial, endotoxin and particulate contamination, including but not limited to:

识别无菌工艺、无菌干预及相关管理,在无菌工艺方面和从风险角度评估来评估他们的可接受性;Identification of aseptic manipulations and interventions and associated controls in parenteral processes and use of risk-based approaches to evaluate their acceptability;

根据风险评估支持环境监测的性能确认方案的采样位置选择和最终常规环境监测取样点位置的识别;

Execution of risk-based approaches to identify areas of highest risk in support of sampling location selection in Environmental Monitoring Performance Qualification protocols and eventual identification of routine EM sampling sites;

领导现场无菌检查及自检,包括观察报告和建议的分享;

Leads site aseptic checks self-inspection program including sharing of observations and recommendations;

主导或协商进行无菌保证相关或不一致事件的调查;

Leads or provides consultation for investigation of sterility assurance related events and non-conformances.

制定/维护现场培训项目和无资格认证

等等

Develop/maintain site programs for training and qualification;

etc.

制定验证策略和方案;

Develop Validation Strategy;

起草相关验证方案及报告;

Initiate related validation protocols and reports

主导或协商进行清洁和灭菌相关或不一致事件的调查;

Leads or provides consultation for investigation of Cleaning and Sterilization related events and non-conformances.

对清洁和灭菌过程进行工艺监控,确保工艺处于验证状态;

等等

Perform process monitoring for cleaning and sterilization process, ensure the process is within validated status;

etc.

支持持续改进项目。

Support CI projects.

接受主管的委派。

Accept delegation from supervisor.

职位要求

• 熟悉GMP 管理规范。

Familiar with GMP knowledge.

• 具备较强的文件管理和项目管理能力

Strong document management and project management skills

• 具备较好的操作能力

Strong operation skills

• 具备较强的沟通和团队协作技能

Strong communication and partnering skills.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( LillyRecruitingCompliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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.

At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people.​ We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!

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