Job Description

职位描述

技术转移工艺工程师负责为 pMDI 生产提供技术支持，包括调查和çº æ­£ä¸Žå·¥è‰ºç›¸å…³çš„é—®é¢˜ä»¥åŠåç¦»æ ‡å‡†çš„æƒ…å†µã€‚æ‹…ä»» pMDI 整体工艺和运营的 SME。可能领导并深入参与转入或从工厂转出的 TT。负责 VMP/VMR 和 VP 以及清洁验证，以符合 GMP 和 AZ æ ‡å‡†ã€‚ä½¿ç”¨æ•°æ®ç§‘å­¦å’Œæ•°å­—è§£å†³æ–¹æ¡ˆç¡®ä¿ CPV。

The TS process engineer is responsible for providing technical support for pMDI production including investigation and correction of process-related problems and deviations from standards. Serve as SME for overall pMDI process and operation. May lead and deeply involved in TT to and from site. Responsible for VMP/VMR and VP and cleaning validation to compliance with GMP and AZ standards. Ensure CPV by using data science and digital solutions.

职责（包括关键结果领域、具体责任、任务等） Job Responsibilities (to include key result areas, specific accountabilities, tasks, etc.)

• 从技术和流程角度确保 pMDI 工厂顺利启动 BAU
• å…¨é¢å‚ä¸Žç”Ÿäº§çº¿è®¾è®¡ã€å»ºé€ ã€ç¡®è®¤å’ŒéªŒè¯æ´»åŠ¨ï¼Œå¹¶å°†é’å²› pMDI å·¥åŽ‚æ‰“é€ ä¸ºè‡ªåŠ¨åŒ–æ™ºèƒ½å·¥åŽ‚ã€‚
• 确保技术文件、SOP/WI 建立以用于 BAU 并满足 GMP/SHE 要求，提高 AZSS 成熟度，提高流程稳健性和产率以及团队其他的 SQSCP相关 KPI
• 建立数字化解决方案和数据分析能力
• 确保 SAP/MES 主数据、BOM 处方和 PV 的建立可用于BAU 和持续改进
• 支持经理进行验证，清洁策略的制定和实施，CPV 等活动
• 为 pMDI äº§å“æä¾›æŠ€æœ¯æ”¯æŒï¼ŒåŒ…æ‹¬è°ƒæŸ¥å’Œçº æ­£ä¸Žå·¥è‰ºç›¸å…³çš„é—®é¢˜ä»¥åŠåç¦»æ ‡å‡†çš„æƒ…å†µ
• 负责确定并执行项目以降低成本、提高产品质量、提高产量和减少材料使用量
• 与 PETã€åŽ‚æˆ¿å’Œå…¬ç”¨è®¾æ–½ã€è‡ªåŠ¨åŒ–å’Œè´¨é‡éƒ¨é—¨åˆä½œï¼Œä»¥æé«˜ç”Ÿäº§åŠ›ã€äº§é‡ã€äº§å“è´¨é‡å’Œä¾›åº”å¯é æ€§
• 设计并执行变更已批准的工艺确认和验证
• æ ¹æ®éœ€æ±‚å‘èµ·ä¸Ž pMDI 相关的变更并交付，以符合 GMP/SHE 和 AZ的要求
• ç¼–å†™ã€æ›´æ–°ã€å®¡æ ¸å¹¶æ‰¹å‡†åŒºåŸŸç›¸å…³æµç¨‹ï¼Œä»¥ç¡®ä¿å†…å®¹æ­£ç¡®å¹¶ç¬¦åˆ GMP的要求
• 在内部审计和监管检查期间担任影响 pMDI 操作的技术项目 SME
• 参与TOSI 和其他工厂（如 AZDP）的新技术、设备和工艺的 TT 和实施
• 作为产品所有者，提高与 pMDI äº§å“ç›¸å…³çš„ç”Ÿäº§åˆ¶é€ ç³»ç»Ÿçš„è´¨é‡å’Œæœ‰æ•ˆæ€§ã€‚è¿™åŒ…æ‹¬è®¾è®¡ã€æ‰§è¡Œå’Œè¯„ä¼°å®žéªŒè®¡åˆ’ï¼Œä»¥ç¡®å®šæ‰€éœ€çš„å·¥è‰ºèƒ½åŠ›ã€æ ‡å‡†å’Œç¨³å¥æ€§ã€‚
• 负责为新的和现有的 pMDI 产品和流程提供制药工艺支持
• 开发产品/工艺知识
• 领导或参与 TT 活动
• 参与URS/FAT/SAT/PQ/PV
• 使用数字化和精益工具进行统计学过程控制和过程能力分析
• 调查并执行非预期趋势或结果的 PPS 和 RCAï¼ŒæŒç»­æ”¹è¿›æµç¨‹å¯é æ€§å’Œç¨³å¥æ€§
• 从技术和数据分析角度贡献于自动化工厂愿景
• 维护符合 SHE 要求的安全工作场所
• 按照 GMP、AZ 政策、SOP 和 WI 执行工作
• SAP/系统主数据所有者，包括 BOM、处方、PV 建立和维护
• Ensure pMDI site smoothly startup for BAU from technical and process perspective
• Fully involved in production line design, construction, qualification and validation activities and deliver Qingdao PMDI site as autonomous and smart factory.
• Ensure technical documentation, SOP/WI setup ready for BAU and meeting GMP/SHE requirement and improve AZSS maturity and improve process robustness and production yield and other SQSCP KPI for the team
• Digital solutions and data analysis capability buildup
• Ensure SAP/MES master data, BOM recipe and PV setup ready for BAU and continuous improvement
• Support manager on validation, cleaning strategy and implementation, CPV etc activities
• Provides technical support for pMDI products, including investigation and correction of process-related problems and deviations from standards
• Responsible for identifying and executing projects to reduce cost, improve product quality, improve yield and reduce materials usage
• Collaborates with PET,Facility and Utility, Automation,and Quality to optimize productivity, yield, product quality and supply reliability
• Designs and executes process qualifications and validations for approved changes
• Initiate pMDI related change proposals as required and delivered to compliance with GMP/SHE and AZ standards
• Authors, updates, reviews and approves area procedures to ensure correct content and compliance with GMP
• Serves as SME for technical projects affecting pMDI operation during internal audits and regulatory inspections
• Participate TT and implementation of new technologies, equipment and processes from TOSI and other sites such as AZDP
• Enhance quality and effectiveness of manufacturing systems related to pMDI products as product owner. This includes the design, execution and evaluation of experimental plans to ascertain the required process capabilities, specifications and robustness.
• Responsible for providing pharmaceutical process support to new and existing pMDI products and processes
• Develop product/process knowledge
• Involve in TT activities
• Contributes to URS and participants in FAT/SAT/PQ/PV
• Conducts statistical process control and process capability analysis with digital and lean tools
• Investigates and conducts PPS and RCA of unexpected trends or results and continuous improve on process reliability and robustness
• Autonomous site vision contribution from technical and data analysis perspective
• Maintains a sate workplace to compliant with SHE requirement
• Executes work in compliance with GMP, AZ policies, SOP and WI
• SAP/System master data owner including BOM, recipe, PV setup and maintain

å…¸åž‹èŒè´£ï¼ˆæ ¹æ® AZ 框架和监管要求）Typical Accountabilities (per AZ framework and regulatory expectations)

• å¼€å±•ç¬¦åˆå…¬å¸ä»·å€¼è§‚çš„æ´»åŠ¨å’Œäº’åŠ¨ï¼Œå¹¶éµå®ˆä¸Žæ‚¨çš„èŒä½ç›¸å…³çš„é“å¾·è§„èŒƒå’Œæ”¯æŒæ”¿ç­–å’Œæ ‡å‡†ï¼ˆåŒ…æ‹¬ SHE）。按时完成 AZ é“å¾·è§„èŒƒå’Œæ”¯æŒæ”¿ç­–å’Œæ ‡å‡†çš„æ‰€æœ‰å¿…éœ€åŸ¹è®­ã€‚æŠ¥å‘Šæ½œåœ¨çš„ä¸åˆè§„é—®é¢˜ã€‚
• Conduct activities and interactions consistent with Company Values and in compliance with the Code of Ethics and supporting Policies and Standards relevant to your role (including SHE). Complete all required training on the AZ Code of Ethics and supporting Policies and Standards on time. Report potential issues of non-compliance.

Date Posted

02-4月-2026

Closing Date

30-10月-2026

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 authorization and employment eligibility verification requirements.