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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 35,000 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.

主要职能

  • 在内部评估/审核和外部监管检查中代表/维护工厂无菌保证策略。参与审查无菌保证的各方面情况的自检活动。

Represent/defend site sterility assurance strategies during internal assessments/audits and external regulatory inspections. Participate in self-inspections, aimed at ascertaining specific aspects of sterility assurance.

  • 与PQ,APS和PV阶段一样,参与/协调生产活动中的无菌保证问题的调查和解决以及重新验证/重新确认。

Participates / coordinates the investigation and resolution of Sterility Assurance issues in operational activities and in revalidation / requalification as in the PQ, APS and PV phase.

  • 领导工厂无菌检查及自检,包括分享观察报告和提出建议。

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

  • 在无菌保证相关事件和不一致事件的调查中作为主导角色或顾问角色。评估,确定在无菌操作过程中使用的消耗品,并参与/协调调查与消耗品的使用相关的问题。

Leads or provides consultation for investigation of sterility assurance related events and non-conformances. Evaluate, identify consumable items used in aseptic processes and participates / coordinates investigation of issues associated with their use.

  • 评估变更对无菌保证方面的影响,并实施和管控制定的行动。

Evaluate the impact of changes in relation to aspects of Sterility assurance and then implements and controls the agreed actions.

  • 了解生产无菌注射剂产品相应的科学原理,包括设备、无菌工艺和容器密闭系统之间的相互作用。

Understand the scientific principles required for manufacturing parenteral drug products, including the interactions between equipment, aseptic processes and container closure systems.

  • 从风险角度考虑,评估现有的无菌注射剂产品的生产工艺及对潜在的微生物,内毒素和颗粒物的污染的控制。

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.

  • 确定注射剂生产工艺中的无菌操作和无菌干预,以及相关控制,并从风险角度评估其可接受性。

Identification of aseptic manipulations and interventions and associated controls in parenteral processes and use of risk-based approaches to evaluate their acceptability.

  • 从风险角度考虑,以确定风险最高的区域,在环境监测的性能确认方案中定义所选的采样位置以及最终定义常规环境监测取样点位置。

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.

  • 评估人员在无菌管控方面的表现,对无菌区人员进行周期性再培训,对首次进入无菌区并在分级区工作的人员进行培训;作为RABS灌装工艺的一个组成部分,人员培训及评估是定义培养基模拟灌装期间的员工再培训策略的一个因素。

Evaluates the performance of people in terms of aseptic handling, performs periodic retraining of personnel with access to the aseptic block, trains people who have to enter the aseptic block for the first time and work in classified areas; as part of the RABS filling process, it participates in the definition of staff retraining strategies during APS

  • 确保准确的指令系统(批记录和标准操作规程)和工艺流程文件来描述实际工艺步骤中执行的工艺流程及无菌保证控制策略。

Ensure that an accurate instruction set (batch records and procedures) and PFD describe the process as performed and the control strategy for sterility assurance in the discrete manufacturing steps.

  • 掌握可衡量生产工艺能力的相关数据来理解、证明和记录验证状态(工艺验证及其他相关的验证活动,包括清洁验证和无菌工艺模拟),来满足既定目标。

Understand, justify and document the state of validation (process validations and other related validation activities including aseptic process simulation APS) with data that evaluate the capability of the manufacturing process to meet its stated purpose.

  • 准备、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.

  • 开发,监控,并在实际环境和人员监测上对已建立的基于统计学基础的指标进行适当回应,评估潜在风险。

Develop, monitor and appropriately react to established statistically based metrics in real-time environment and personnel monitoring to assess potential risk.

  • 实施以下策略:APS,过滤验证,EMPQ,消毒,灭菌,去热原,防渗漏管控,手套管控,更衣管理,生物颗粒物表征,清洁验证(微生物方面),消毒剂验证和容器密闭性验证。

Implements the strategies of APS, Filtration Validation, EMPQ, Sanitization, Sterilization, Depyrogenation, Leaks Mngt, Glove Mngt, Gowning, Biological Particle characterization, Cleaning validation (microbiological aspects), validation of sanitizing agents and Container Closure Validation.

  • 准备和/或审核与无菌保证相关的EMPQ / PQ / APS / PV / QRM /法规文件

Prepares and / or reviews EMPQ / PQ / APS / PV / QRM / Regulatory documents relating to aspects of Sterility Assurance

  • 接受主管的委派。

Accept delegation from supervisor.

  • 参与工艺团队的开发和实施,以积极的方式实施TS / MS目标,并达成业务和质量目标。

Participate in development and implementation of process teams in positive fashion to implement TS/MS objectives and deliver on business and quality objectives.

  • 可能需要在与无菌保证有关的Network Lilly活动中进行合作

May need to collaborate in Network Lilly activities related to Sterility Assurance

  • 支持持续改进项目。

Support CI projects.

基本要求:

  • 遵守所有的安全政策、标准和准则。

Adherence to all the safety policies, standards and guidelines.

  • 理解GMPs及国内适用的标准。

Understanding of GMPs and applicable internal standards

  • 技术写作和演讲技巧。

Technical writing and presentation skills

  • 良好的书面和口头英语沟通能力。

Good and strong written and oral English communication skills.

  • 良好的团队合作能力和人际交往能力。

Good teamwork and interpersonal skills.

  • 良好的计算机技能。

Good computer skills .

  • 良好的分析思考能力,多重任务处理,作出决策,解决问题的能力

Good skills in analytical thinking, multi-tasking, decision-making and problem-solving.

  • 良好的管理、项目管理能力,有能力影响并引导项目。

Good skills in leadership, project management, ability to influence and lead projects.

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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