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