Lead /Principal Engineer, Packaging Process

Typical Accountabilities

主要职责

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等。

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。

• During contract manufacturing, conduct on‑site supervision of production activities related to AstraZeneca products, ensuring compliance with manufacturing processes, quality standards, and regulatory requirements.

在委托生产期间，对阿斯利康产品生产相关活动进行现场监督，确保符合生产工艺、质量标准等法规要求。

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。

Project Management

项目管理

• Lead or support technical project deliverables on time in full, and compliance with AZ PMF, e.g., CMC variation, TT and continuous improvement.

按照AZ PMF 的要求，领导或支持技术项目的交付，比如CMC variation， 技术转移、持续改进项目等等。

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, Qualification, Experience

Education, Qualifications, Experience and Capabilities 教育、资质、经验和能力

教育、资质、经验

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 required for formulation lead process engineer;
• sterile/aseptic process and microbiology knowledge required for sterile lead process engineer;
• Blister & bottle packing, etc. knowledge required for packing lead process engineer

相应区域的专业知识。

• 包装主管工艺工程师需具备泡罩包装，瓶包装，西林瓶包装及复合袋包装 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/口语优秀

• 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 of CMC variation and TT.

在CMC 变更和技术转移项目上，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

• At least 5 years’ experience in pharmaceutical process

至少具备5年以上的制药技术工作经验

• 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 of CMC variation and TT.

在CMC 变更和技术转移项目上，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

• At least 5 years’ experience in pharmaceutical process

至少具备5年以上的制药技术工作经验

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。