职位描述Job Description

技术转移工艺工程师负责为 pMDI 生产提供技术支持，包括调查和纠正与工艺相关的问题以及偏离标准的情况。担任 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 标准。使用数据科学和数字解决方案确保 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
• 全面参与生产线设计、建造、确认和验证活动，并将青岛 pMDI 工厂打造为自动化智能工厂。
• 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 产品提供技术支持，包括调查和纠正与工艺相关的问题以及偏离标准的情况
• 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 PET、厂房和公用设施、自动化和质量部门合作，以提高生产力、产量、产品质量和供应可靠性
• 设计并执行变更已批准的工艺确认和验证
• 根据需求发起与 pMDI 相关的变更并交付，以符合 GMP/SHE 和 AZ的要求
• 编写、更新、审核并批准区域相关流程，以确保内容正确并符合 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 产品相关的生产制造系统的质量和有效性。这包括设计、执行和评估实验计划，以确定所需的工艺能力、标准和稳健性。
• 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 RCA，持续改进流程可靠性和稳健性
• 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

典型职责（根据 AZ 框架和监管要求）Typical Accountabilities (per AZ framework and regulatory expectations)

• 开展符合公司价值观的活动和互动，并遵守与您的职位相关的道德规范和支持政策和标准（包括 SHE）。按时完成 AZ 道德规范和支持政策和标准的所有必需培训。报告潜在的不合规问题。
• 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.