Sr./Lead Engineer, Process
Technology
阿斯利康常州-无锡-苏州地区, 中国3周前截至 2026/12/24
全职
职位描述
Typical Accountabilities主要职责
Project Management
项目管理
- Enable the streams deliverables to plan, incl., facility/process design, supplier selection, FAT, SAT, qualification, handover, etc.
- Work with all stakeholders to achieve the defined project targets.
- Support stream leaders to ensure the project management under AZ PMF framework, incl., reporting, escalating, communication, change management, etc.
- Conduct communications across client teams to share the progress of the project execution.
- Be as the technical representative to do the impact assessment for each change control via risk-based approach.
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.,
Resources & Knowledge Management
资源&知识管理
- Providing expert guidance and advice in specialist areas. Drives collaboration and knowledge sharing amongst project teams. Support the development of project, and maintenance of Project management skills, processes and capabilities across Site/Operations.
- Utilize lean concepts and tools within the overall management of projects.
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.
- 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.
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
- Professionalism in the Pharmaceutical knowledge and experience; including production processes, validation, trouble shooting, investigation, and continuous improvement
- Knowledge of specific dosage forms.
- Oral Solid Dosage knowledge/Continuous direct compression 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。
- 制剂高级工艺工程师需具备口服固体制剂及连续化生产工艺等相关知识。
- 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
- Strong statistical knowledge with experience in DoE, limit setting etc.,
- Experience in PM, Technical Supports or technical transfer.
- At least 1-year experience in the areas of GMBR/PVL/PMBR creation and update
- At least 5 years’ experience in pharmaceutical process
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