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.
担任工艺团队的 TS / MS代表，为团队提供技术支持：
Serve as TS/MS representative of process team to provide technical support:
•负责确保其专业领域（配液/灯检）以结构化和有效的方式解决复杂的工艺问题，并在必要时扩展到secondary loop。
Responsible for ensuring for its area (inspection) of expertise that complex process issues are addressed in a structured and resolved manner and, if necessary, scaled to the Secondary Loop.
• 支持因变更或项目需求产生的工艺相关研究和验证活动。
Supports process-related studies and validation activities due to change or project.
具体包括In details:
• 主动参与工艺团队的活动。
Actively present/participate Process Team activities.
• 监督工艺能力（工艺受控且稳定）和产量变化，包括：
Overseeing process capability (process in control and capable) and yield variables, including:
a.协助工艺团队确定变异的来源（即常见或特殊原因的变化）并提出适当的改进建议。 Assisting the Process Team with identifying sources of variation (i.e. common or special cause variability) and recommending appropriate improvements.
b.拥有工艺质量平衡以及包括废物在内的产品损失的潜在来源。
Owning the process mass balance and the potential sources of product losses including waste.
• 作为工艺团队和 TSMS部门团队之间的联络点。代表两个团队的关键优先事项并确保一致，必要时向上沟通。
Serve as the point of contact between the process team and TSMS functional team. Represent key
priorities in both teams and ensure alignment, or escalate as needed.
• *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.
• *对工艺及其相关设备、设施、计算机系统和操作有全面的了解。
Have a comprehensive understanding of process flow and associated equipment, facilities, computer systems and operations.
• 在其范围内了解工艺的目的和科学，并全面了解整个工艺。
Understand the purpose and science of the process within their scope and have a thorough understand of the entire process flow.
• 了解操作控制策略并拥有控制策略中与工艺/产品相关的部分，包括工艺参数和其他输入变
量(CPP, CIPC等)如何潜在地影响关键质量属性（CQA），以及历史上和潜在工艺故障模式
与他们的相关对策（例如 iMCS）。
Understand the Operational Control Strategies and own the process /product related portions of the Control Strategy including how the process parameters and other input variables (e.g. CPP and CIPC) can potentially impact the Critical Quality Attributes(CQA),as well as the historic and potential failure modes for the process and their associated countermeasures (e.g. iMCS).
• 了解产品/工艺控制因素，分析控制策略以及发展和验证历史。
Know the product/process control factors, the analytical control strategy and the development and validation history.
• 确保有准确的工艺流程文件（PFD）其中描述了工艺，分析方法，控制策略，工艺参数，关键质量属性（CQA），并包括对支持数据的引用。
Ensure there is an accurate Process Flow Document (PFD) that describes the process, analytical methods, the control strategy, the Process Parameters, Critical Quality Attributes(CQA)and includes references to supporting data.
• 执行日常监控，进行适当的产品和工艺评估（例如，连续生产总结，年度产品检查等）以及适当的再验证活动。
Leverage routine monitoring, appropriate product and process assessment (e.g. end of campaign summaries, Annual Product Reviews, etc.) and re-validation activities as appropriate.
• 参与工艺的设计和执行，清洁，无菌和生物负荷控制策略，分析转移和验证活动。
Participate in the design and execution of process, cleaning, sterility and bioburden control strategies, analytical transfers and validation exercises.
• 代表 TS / MS通过以下方式为日常运营管理提供支持：
The TS/MS Representative provides support to the management of daily operations by:
• 使用统计工具来了解并适当减少变异的来源。
Using statistical tools to understand and appropriately reduce the source of variability.
• 使用 data historian和其他工艺数据源来提取和绘制相关的工艺参数。
Using data historian and other sources of process data to extract and chart relevant process parameters.
• 领导工艺相关的根本原因分析，并在所有调查中提供专业的工艺知识。
Leading process related Root Cause Analysis and providing expert process knowledge in all investigations.
• 负责工艺相关的偏差，投诉，纠正和预防措施以及变更。
Owning process related deviations, complaints, corrective and preventative actions, and changes.
• 确保工艺变更不会对产品质量产生不利影响。
Ensuring changes to process have no adverse impact on product quality.
• 负责批记录和修订，并确保它们处于最新和准确的状态。
Owning the batch records and revisions, and ensuring they remain current and accurate.
• 培训、指导并持续强化工艺团队成员和前线员工的相关关工艺知识，例如 Process School。
Educating, coaching and providing ongoing reinforcement of Process Team members and frontline
staff on the process e.g. Process School.
• 确保批准与工艺相关的规程和指导安装书面所写的要求被执行，以达到实践与规程相匹配,
例如 PMX, SOP/WI。
Ensuring approved process-related procedures and instructions can be executed as written so that practice matches procedure, e.g. PMX, SOP/WI.
• 在适当的情况下与产品保护组，清洁组和组件专家进行联络。
Serving as the liaison with the Product Protection groups, cleaning groups, and component stewards, where appropriate.
• 作为与工艺团队之外的其他科学和/或技术专家（例如，产品专家，开发科学家或其他人员）进行联络的桥梁，以解释工艺控制数据及其对工艺控制策略的影响。
Serving as a liaison to other scientific and/or technical experts outside the process team such as Molecule Stewards, development scientists or others as needed to interpret process control data and resulting implications for process control strategies.
• 接受主管的委派。
Accept the delegation from supervisor
• 完成主管安排的其它工作任务。
Finish the other duties assigned by supervisor.
基本要求Basic Requirement：
• 深入了解整个工艺流程，全面了解工艺及其相关设备，厂房，计算机系统和操作。
Thorough understanding of the entire process flow, and holistic understanding of the process and its associated equipment, facilities, computer systems and operations
• 具有独立的工作能力及良好的团队合作能力。
Demonstrated ability to work independently and a good team-player.
• 良好的口头及书面沟通技巧，包括英文沟通能力和技巧。
Good and strong written and oral communication skills including strong English skills
• 良好的计算机技能。
Good computer skills.
其他要求Other Requirement：
• 具有较强的分析、处理多个任务、做决策及解决问题的能力更佳。
Good skills in analytical thinking, multi-tasking, decision-making and problem-solving is a plus. • 具有较强的领导及项目管理能力更佳。
Good skills in leadership and project management with ability to influence across multiple levels of organization and with strong interpersonal skills is a plus.
• 制药工业中 0-5年的 GMP经验，无菌产品经验更佳。
0 - 5+ years GMP experience in pharmaceutical industry, preferably related to packaging, and/or parenteral manufacturing is a plus
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.
#WeAreLilly