• 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 issues to enable process robustness.
• 解决技术问题，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。
• Support new technical project to ensure deliverables to plan, incl. material source change, technical transfer, line expansion, capacity uplift, etc.
• 支持新项目按计划交付, 包括新原料供应商，技术转移，产线扩展，产能提升等。
• Act as technical personnel to support capability uplift of process、manufacturing and quality team
• 作为技术人员，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 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。

Qualification and Validation

确认和验证

• Design qualification/validation and conduct qualification/validation activities based on risk assessment and statistics approach, incl. URS, RTM, Validation plan, validation design and execution, etc.,

基于风险管理和统计学的验证设计和执行，包括URS, RTM, 验证计划、设计和执行等。

• 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。

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 specialists to engage quality, technical and manufacturing team to uplift capabilities.

作为工艺和法规的专家，与技术、质量和生产团队合作以期整体能力提升。

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

• Manage projects to support site business development, e.g. new product introduction, Technical Transfer, supply switch over, production line expansion, continuous improvement, etc.

项目管理支持工厂业务发展，比如：新产品引进，技术转移，供应链切换，生产线产品扩增，持续改进，等等。

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

教育、资质、经验

• University graduate or above

本科毕业及以上

• Familiar with Pharmaceutical knowledge and experience, including production processes, validation, trouble shooting, investigation, and continuous improvement.

精通制药相关知识，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 process engineer;
• sterile/aseptic process and microbiology knowledge required for sterile process engineer;
• Blister & bottle packing, etc. knowledge required for packing process engineer;

• 相应区域的专业知识。

• 片剂工艺工程师需具备口服固体制剂知识，
• 针剂工艺工程师需具备灭菌、无菌工艺以及微生物知识，
• 包装工艺工程师需具备泡罩包装及瓶包装等相关知识。

• GMP and regulatory knowledge

GMP和法规知识

• Familiar with the knowledge of 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

• Basic statistical knowledge

基本的统计学知识

• Knowledge of GMBR/PVL/PMBR.

GMBR/PVL/PMBR相关知识

• At least 3 years’ experience in pharmaceutical process.

至少具备3年以上的制药技术工作经验