(Sr.) Process Engineer

• Collaborate effectively with cross functions (GERE, global SME and stakeholders, external parties, etc) to support the high-quality and efficient deliverables of CDC stream/PP Packing stream related projects, and contribute to build a smart, green factory to achieve autonomous manufacturing and zero carbon.

积极与跨部门团队（GERE、AZ 各领域专家及外部合作方等）高效协作，支持无锡工厂CDC 生产业务模块/PP 包装业务模块相关项目的高质高效交付，助力实现自动化和零碳目标，打造智能绿色工厂。

• Introduce new equipment, new process and new technology according to project strategy and plan, to deliver formulation/packing project on time.

确保按照项目策略计划支持新设备、新工艺、新技术引入，按时按质交付制剂/包装项目。

• Lead new technical project deliverables to plan, incl. material source change, technical transfer, etc.,

确保按照项目策略计划交付, 包括新原料供应商，技术转移等。

• Author production documents, i.e. Batch sheet, EBPR, Forms, SOP, Change, Validation protocol/report, etc.

生产文件的作者，即批生产记录，电子批生产记录，表格，SOP，Change，验证方案/报告等。

• Design and conduct qualification, process validation and cleaning validation.

设计并执行确认、工艺和清洁验证。

• Handle problem solving or technical investigation for the complex issues to enable process robustness

解决复杂的技术问题，确保工艺稳健。

• Drive continuous improvement of process robustness.

领导工艺稳健的持续改善。

• Lead product/process ownership, incl. CPP, CMA, CQA and CPV, etc.,

负责产品/工艺，包括关键工艺参数，原料和产品质量属性，持续工艺确认等。

• Act as technical coach to support capability uplift of process, manufacturing and quality team.

作为技术专家，帮助技术、生产和质量团队提升技术能力。

• Work with internal and external stakeholders to manage technical affairs.

紧密与内外部的利益相关者合作管理技术相关的事务。

Typical Accountabilities

主要职责

Project Management

项目管理

• Enable the streams deliverables to plan, incl., facility/process design, supplier selection, FAT, SAT, qualification, handover, etc.

确保相关业务模块成果按计划交付，包括厂房/工艺设计、供应商选择、FAT、SAT、确认、移交等。

• Work with all stakeholders to achieve the defined project targets.

紧密与所有利益相关者合作，设计和交付项目目标。

• Support stream leaders to ensure the project management under AZ PMF framework, incl., reporting, escalating, communication, change management, etc.

支持相关业务模块负责人确保AZ PMF 框架下的项目管理，包括报告、升级、沟通、变更管理等。

• Conduct communications across client teams to share the progress of the project execution.

与用户团队进行沟通，分享项目实施的进展情况。

• Be as the technical representative to do the impact assessment for each change control via risk-based approach.

作为技术代表，对每个变化在考虑风险的基础上进行影响性评估。

Qualification and Validation

确认和验证

• To update SVMP and ensure the visibility of validation plan execution status across the site;
• 更新工厂验证主计划，确保其执行状态的可见性；
• To coordinate with the site QSR implementation;
• 协调工厂QSR的实施
• To give the training on the validation concept and local validation document requirement as requested;
• 根据要求，对工厂验证概念和验证文件进行培训；
• To draft VMP/VP as appropriate;
• 起草验证主计划/计划（如适用）；
• To review and approve the validation doc as appropriate;
• 审核和批准验证文件（如适用）；
• Be as the validation representative to facilitate the validation work across the project;
• 作为验证代表，推进整个项目的验证工作；
• Be as the validation representative to do the validation assessment for each change control via risk-based approach;
• 作为验证代表，对每个变更控制在考虑风险的基础上进行验证评估；
• To generate/maintain the validation Doc template for each type of validation;
• 制定/维护验证模板；
• To generate/maintain the validation training package.
• 制定/维护验证培训材料。
• Manage qualification and validation related change activities, e.g., supply switch over management, validation batches release management, etc.,

管理验证相关的其他活动，比如供应切换，验证批的放行管理等。 Resources & Knowledge Management

资源&知识管理

• Providing expert guidance and advice in specialist areas. Drives collaboration and knowledge sharing amongst project teams. Support the development of project, and maintenance of Project management skills, processes and capabilities across Site/Operations.

在专业领域,提供专家指导和建议。促进项目团队之间的协作和知识共享。支持项目的发展以及项目管理技能，流程和能力的开发和维护。

• Utilize lean concepts and tools within the overall management of projects.

在整个项目管理过程中利用精益理念和工具。

Process Development and Improvement

工艺开发和优化

• Investigate issues encountered during routine production; provide the technical evaluations and studies (e.g. DOE) to drive process robustness.

调查日常生产过程中遇到的问题, 进行技术评估和研究(比如实验设计)，改进工艺稳健性。

• Take product and process ownership to conduct CPV, identify improvement opportunities, address the risks, and take proactive actions.

持续工艺确认， 识别风险和机会，并采取措施。

• Work with internal and external stakeholders, e.g., quality, supply chain, manufacturing, M&ST, Ops Regulatory, China RA, etc., to manage technical related affairs, such as GCE, CMC variation projects, etc.,

和内外部的利益相关者合作，管理技术相关的事物，比如仿制药一致性评价，CMC的变更项目等。

• Act as the process and regulatory experts to coach quality, technical and manufacturing team to uplift capabilities.

作为工艺和法规的专家，指导技术、质量和生产团队的能力提升。

Documentation

文件

• Author technical related SOP, WI, BRP, EBR, Technical Reports, Validation documents, etc., ensure master data is accurate.
• 撰写技术相关的SOP，WI, 批记录、电子批记录、技术报告、验证文件等；确保主数据维护的准确
• Author technical training materials and manage product knowledge

撰写技术培训材料，并管理产品知识。

SHE Responsibility

SHE责任

• Compliance with AZ code of conduct and SHE requirement.

符合公司的行为规范和SHE的要求 Technical Layout and Artwork Management (Apply to Packaging Engineer)

技术图纸以及包装设计管理（适用于包装工艺工程师）

• Maintain the current technical layout and create the new technical layouts for new products.

维护现有的技术图纸，为新产品创建新的技术图纸。

• Ensure the Gazelle system works well in Wuxi site

确保Gazelle系统在无锡正常运行。

• Issue the specification for the new materials/components

制定新材料的质量标准

MBR author

主批报记录撰写人

• Update GMBR, create and update PVL/PMBR

更新GMBR，创建和更新PVL/PMBR

• Deliver different level training to Wuxi site operators as required.

按照需要对无锡工厂的操作员工进行不同程度的培训。

• Handle any PAS-X system technical issues during BAU phase.

在BAU 阶段解决PAS-X 系统的技术问题。 Education, Qualifications, Experience And Capabilities 教育、资质、经验和能力

University graduate or above

本科学历/以上

• Professionalism in the Pharmaceutical knowledge and experience; including production processes, validation, trouble shooting, investigation, and continuous improvement

专业级的制药知识，包括生产工艺、验证、问题解决、调查和持续改进。

• Knowledge of specific dosage forms.
• Oral Solid Dosage knowledge/Continuous direct compression knowledge required for formulation senior process engineer;
• sterile/aseptic process and microbiology knowledge required for sterile senior process engineer;
• Blister & bottle packing, etc. knowledge required for packing senior process engineer;
• 相应区域的专业知识。
• 制剂高级工艺工程师需具备口服固体制剂及连续化生产工艺等相关知识。
• 包装高级工艺工程师需具备泡罩包装和瓶包装等相关知识。
• GMP and regulatory knowledge

GMP和法规知识

• Professionalism in process and cleaning validation

精通工艺验证和清洁验证知识

• Excellent written/Oral English

英语书写/口语流利

• High level of computer skills

精通电脑

• Strong statistical knowledge with experience in DoE, limit setting etc.,

扎实的统计学知识，具备实验设计、限度设定等统计学应用经验

• Experience in PM or Technical Supports or TT.

具备项目管理或技术支持的经验

• At least 1-year experience in the areas of GMBR/PVL/PMBR creation and update

在GMBR/PVL/PMBR创建和更新方面拥有至少1年的从业经验

Capabilities

能力

• Risk Management, analysis and problem solving;

风险评估、分析和问题解决;

• Project Management;

项目管理;

• Pharmaceutical process with data analysis;

制剂工艺和数据分析;

• Writing Capability;

写作能力;

• GXP and Quality Management;

GXP和质量管理;

• Analytical method and specification;

分析方法和质量标准;

• CMC and Regulation;

CMC和法规;

• Finance evaluation;

财务分析; Strong leadership capability in communication,

coordination, influence, judgement, coach and emotion intelligence.

较强的领导力，包括交流、协作、影响力、判

断力、指导和情绪智商。

• At least level 2 of MBR author skill.

至少达到主批报记录撰写人的2级技能要求。