Lead Specialist-Operations

<p style="text-align:left">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.</p><p style="text-align:inherit"></p>在无菌制剂运营部发挥领导作用。Lead Specialist负责日常运营，发展操作员，确保遵守所有政策/规程，确保根据生产计划安排相应的资源。 To provide line leadership in Parenteral Operations. The Operations Shift Specialist is responsible for the daily operations, development of operators, ensuring compliance with all policies/ procedures, ensuring resources are scheduled accordingly per the Operations schedule. 安全： Safety: 确保严格遵守HSE的政策/规程。确保对操作员进行适当的培训。 Ensure strict compliance with established HSE policies/procedures. Ensure operators are trained appropriately. 质量 Quality: 确保严格遵守QA/生产的政策/规程。确保对操作员进行适当的培训。（操作规程，消毒，更衣等） Ensure strict compliance with established QA/Operation policies/procedures. Ensure operators are trained appropriately (Operations Procedures, Sanitization, Gowning, Etc.). 确保所有操作员的培训与他们正在执行的操作保持一致。 Assure that all the operators are trained for the tasks they are performing. 确保始终遵循良好的文件书写习惯 Assure that Good Documentation Practices are always followed. 在Trackwise系统中记录发现项。负责实施与审核、观察、检查发现项和与制造/包装区域相关偏差的措施。 Issues observations in the Trackwise system. Take ownership for implementation of countermeasures associated with audits, observations, inspection findings, and deviations relative to manufacturing areas. 流程 Process: 为产线的各个工艺/生产问题提供初步支持。收集评估所需的初始数据。遵循上报流程，并将初步发现报告给流程团队。 Provides initial support for any process/production issues on the floor. Collects initial data needed to evaluate the situation. Follows the escalation process and reports initial findings to the process team. 作为生产/包装生产线的技术人员给操作员演示规程知识，复核环境监控及无菌保障的要求以及相关技术。为操作员提供指导和技术资源。担任资质认定计划（QP）的讲师。 Technical leader on manufacturing line, setting good example, has demonstrated knowledge of procedures, compliance with quality systems EM and SA requirements and use of proper techniques. Mentor and technical resource for operators. Serves as trainer for the Qualification Program (QP). 向一线主管提供有关设备或工艺步骤，车间活动（例如维护，固定资产项目，采样，工作许可证等）以及实现一线生产计划的进度的信息。 Provide information on the equipment or process step performance, status of floor activities (such as maintenance, capital projects, special sampling, work permits, etc.) and progress toward achieving the shop floor production plan to the frontline supervisor. 实时并连续地收集、维护和监控工艺过程，并提出问题使一线主管注意。（例如，按批次执行设备基本检查，收集和报告设备故障诊断数据） Collecting, maintaining, and monitoring the process on a real-time and continuous basis, and bringing any concerns to the attention of frontline supervision. (In example performing equipment basic Check by Batch, collecting and reporting data for equipment troubleshooting) 部门： Function: 根据生产计划表，设备/工艺状态和日常运营计划管理车间运营，以确保安全和高质量地有效执行所有车间支持。领导所有车间活动的支持（包括Zero Loop的资源）的操作和任务的计划/协调。与各个区域联络，以验证组件和设备可用于制造。积极参与交接班中设备、工艺状态以及任何需要解决或上报的问题的讨论。 Manages shop floor execution according to the production schedule, equipment/process status, and daily operations plan ensuring efficient execution of all floor support with safety & quality. Leads planning/coordination of operations and tasks for all floor support, including zero loop resources. Network with various areas to verify components and equipment are available for manufacturing. Active participant in shift handover communications of status of equipment, process, and any issues needing resolution or escalation 协助主管进行操作员和Zero Loop维护技术人员的发展，性能评估。作为Supervisor的backup。接受过人为错误预防（HEP）流程的培训，并识别改进方案。 Assist Operations Manager in development, performance evaluation of operators and zero loop maintenance technicians. Serves as backup for Operations Manager. Trained on Human Error Prevention (HEP) process and identifies improvement ideas. 将可能影响一线员工遵守书面规程能力的任何差距上报主管。 Escalate to supervision any gaps that could impact the frontline staff’s ability to follow procedures as written. 跨部门： Cross Function: 向流程团队生成并上报持续改进和精益思想。 Generates and escalates Continuous Improvement and Lean ideas to the process team. 支持PT执行PVP，包括从车间收集意见并实施良好实践等。这包括PMX，WI和SOP。 Support the PT for the PVP execution, includes collecting the comments from shop floor and implementing the good practice etc. This includes ensuring PMX, Work Instructions, and SOPs. 为产线上的各个工艺/生产问题提供初步支持。收集评估情况所需的初始数据。遵循上报流程，并将初步发现报告给流程团队。 Provides initial support for any process/production issues on the floor. Collects initial data needed to evaluate the situation. Follows the escalation process and reports initial findings to the process team. 确保将任何可能危害环境，安全或质量的问题上报给主管或流程团队的任何成员。 Assure the escalation to supervision or any member of the Process Team of any issue that has the potential to compromise the environment, safety or quality. 基本要求： Basic Requirements: 具有制药工厂相关经验 Pharmaceutical Manufacturing Experience. 对制造环境中的质量体系有深入的了解。 Strong understanding of quality systems in a manufacturing environment. 高中学历 High school diploma 其他要求： Additional Preferences: 较强的人际交往能力和领导才能与操作员进行沟通。 Strong interpersonal skills and leadership to communicate with operators. 其他信息： 包括履行该岗位所需的工作时间安排（轮班或加班），出差或环境要求。 Other Information: Include any work schedule (shift, overtime), travel or environment requirements necessary for the performance of the position. 接受翻班加班（如业务需求，包括夜班） Flexible to work on shift, overtime, weekends, off-shifts (Such as business needs, including night shift). 能够佩戴安全设备（安全眼镜，安全鞋，防护手套，呼吸器等） Ability to wear safety equipment or special Gowning (safety glasses, safety shoes, protective gloves, respirator, classified areas gowning etc.)<p></p><p>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 (<a href="https://careers.lilly.com/us/en/workplace-accommodation" target="_blank">https://careers.lilly.com/us/en/workplace-accommodation</a>) 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.</p><p></p><p>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.</p><p></p>#WeAreLilly