(Sr./Principal) TS/MS Engineer - Commercialization

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.

Responsibilities:

•    领导并管理新产品/技术转移及其他商业化项目，包括遵循本地和总部项目管理流程运转项目团队、为法规注册和后续上市后变更（包括但不限于原辅包物料变更/工艺变更/基于持续改进的业务变更）、工艺优化等业务提供支持。必要时作为技术代表同时支持生产运营的相关业务需求。
Lead and manage new product/process tech transfer & commercialization projects, including run project team per local and global project governance process, the required support to regulatory registration, post approval changes including but not limited to material change, process change and continuous improvements, and process improvements. Support the floor operation as technical rep when required.

•    准备、审核、批准相关项目管理/技术文件并提供其他产品生命周期内所需技术支持。如：变更管理，法规注册，偏差调查，验证方案及总结报告，生产记录，规程，工艺流程文件，验证计划和年度质量回顾。积极参与工艺团队以实现TS/MS目标和业务及质量目标。
Prepare, review, approve of relevant project/technical documents, and provide technical support throughout parenteral products lifecycle as required, such as: change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, Process Flow Documents, Validation Master Plan, and Annual Product Review.  Participate in development and implementation of process functional teams in positive fashion to implement TS/MS objectives and deliver on business and quality objectives.  

•    遵守HSE各项管理流程，履行安全生产职责要求。
Follow various HSE management procedures and fulfil the work safety responsibilities. 

•    接受主管的委派。
Accept delegation from supervisor.

Basic Requirements:

•    具备良好的分析思维、多任务管理、决策和解决问题的能力。
Good skills in analytical thinking, multi-tasking, decision-making and problem-solving.

•    具备良好的项目管理，影响力和领导项目的能力。  
Good skills in project management, ability to influence and lead projects. 

•    具有丰富的GMP知识和注射剂制造经验。
Knowledgeable with GMP and experienced in parenteral manufacturing.   

•    具有良好的英语沟通能力。
Good and strong English communication skills.  

•    良好的数据处理技能。
Good data analysis skills. 

Additional Skills/Preferences:

•   良好的书面和表达能力。

Good written and presentation skills.

•   良好的团队合作精神和人际沟通关系技巧。

Good teamwork and interpersonal skills.

Additional Information:

•    申请人将工作于无菌生产工厂的各个区域。
Applicant will work in various areas within the Parenteral Plant. 

•    能每天从周一到周五工作8小时。
Ability to work 8 hours’ days- Monday through Friday.

•    能够根据要求加班并能及时对应生产出现的问题。
Ability to work overtime as required and available off shift to respond to operational issues.

•    适当数量的出差。
Reasonable amounts of travel will be required.

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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