Eli Lilly and Company(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.
Job Summary:**
负责产品商业化项目，包括新产品/工艺技术转移，工艺优化，上市后变更及相关项目管理偏差调查，并为法规注册提供支持。需要时支持第一梯队。
The (Sr./Principal) TS/MS Engineer – Commercialization is responsible for commercialization project, including new product/process technology transfer, process improvements, post-approval changes and corresponding project management, deviation investigation and support for regulatory registration. Support primary loop as needed.
Job Responsibilities:**
- 领导并管理无菌制剂新产品/技术技术转移，包括技术转移项目管理、所需产品开发研究，法规注册支持和后续上市后变更、工艺优化等业务。同时支持第一梯队和生产运营的相关业务需求。Lead and manage new parenteral product/process tech transfer & commercialization projects, including development technical study, the required support to regulatory registration, post approval changes and process improvements. Support the TS/MS primary loop and operation as required.
- 根据需要，准备、审核、批准相关技术文件和提供技术支持，并熟练GMP环境中在电子系统中的执行。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 and provide technical support for preparation of relevant technical documents, with hands‑on experience to managing the documentation under electronic systems in a GMP environment as required, such as: change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs, VMPs, and APRs. 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.
- 完成主管安排的其它工作任务。Finish the other duties assigned by supervisor.
- 接受主管的委派。Accept delegation from supervisor.
Job Qualifications:**
- 至少三年无菌制剂企业GMP环境下工作经验。Minimum three years of relevant experience in parenteral manufacturing site within a cGMP environment.
- 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.
- 具备良好的系统性学习能力,项目管理,影响力和领导项目的能力。 Good skills in learning agility, 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.
- 良好的跨部门合作能力和人际沟通关系技巧。Good collaborative skills and interpersonal skills.
- 具有良好的英语沟通能力。Good and strong English communication skills.
- 良好的计算机技能。Good computer skills.
- 良好的书面和口头沟通能力。Good written and oral communications.
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.
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