制剂工艺高级工程师（无菌）

1.Author production documents, i.e. Batch sheet, EBPR, Forms, SOP, ChangeValidation 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。
2.Design and conduct qualification, process validation and cleaning validation.
设计并执行确认、工艺和清洁验证。
3.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。
4.Drive continuous improvement of process robustness.
领导工艺稳健的持续改善。
5.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。
6.Lead new technical project deliverables to plan, incl. material source change, technical transfer, line expansion, capacity uplift, etc.,
新项目按计划交付, 包括新原料供应商，技术转移，产线扩展，产能提升等。
7.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。
8.Take people management duty when technical manager is absent.
在技术经理不在时，负责技术团队的人员管理。
9.Work with internal and external stakeholders to manage technical affairs that are assigned by line manager.
在直线经理的任务安排下，和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

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。

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 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。
▪片剂高级工艺工程师需具备口服固体制剂知识，
▪针剂高级工艺工程师需具备灭菌、无菌工艺以及微生物知识，
▪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/口语优秀
•High level of computer skills
精通电脑

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。

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.