Sr. Engineer, Formulation Process
- Wuxi, Jiangsu
- Permanent
- Full-time
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.,
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.
- 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.,
- Act as the process and regulatory experts to coach quality, technical and manufacturing team to uplift capabilities.
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
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.
SHE责任
- Compliance with AZ code of conduct and SHE requirement.
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.
- Ensure the Gazelle system works well in Wuxi site
- Issue the specification for the new materials/components
主批报记录撰写人
- Update GMBR, create and update PVL/PMBR
- Deliver different level training to Wuxi site operators as required.
- Handle any PAS-X system technical issues during BAU phase.
教育、资质、经验
本科学历/以上
- Professionalism in the Pharmaceutical knowledge and experience; including production processes, validation, trouble shooting, investigation, and continuous improvement
- Knowledge of specific dosage forms.
▪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。
▪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
- Professionalism in process and cleaning validation
- Excellent written/Oral English
- High level of computer skills
能力
- Risk Management, analysis and problem solving;
- Project Management;
- Pharmaceutical process with data analysis;
- Writing Capability;
- GXP and Quality Management;
- Analytical method and specification;
- CMC and Regulation;
- Finance evaluation;
- Strong leadership capability in communication, coordination, influence, judgement, coach and emotion intelligence.
- At least level 2 of MBR author skill.