高级无菌生产与设备专家（Senior Sterile Manufacturing & Equipment SME）

高级无菌生产与设备专家 Senior Sterile Manufacturing & Equipment SME一、岗位定位 / Position Summary作为无菌注射剂新工厂建设项目的最终用户代表（End User SME），负责无菌生产工艺、设备及设施全生命周期建设工作，参与工厂设计、设备选型、安装调试、验证确认及投产准备，确保项目满足GMP法规要求及未来商业化运营需求。As the End User Representative for the sterile manufacturing function, this role will support facility design, equipment selection, commissioning, qualification, and operational readiness activities, ensuring compliance with GMP requirements and future commercial manufacturing needs.二、主要职责 / Key Responsibilities2.1.项目建设与设计评审 / Project Design & Review 参与无菌注射剂工厂设计及建设全过程；Participate throughout the design and construction lifecycle of a sterile injectable manufacturing facility.参与生产工艺、设备及厂房设计方案评审；Review manufacturing process, equipment, and facility design proposals.审核生产布局、人流物流及洁净区设计；Evaluate production layouts, personnel and material flows, and cleanroom classifications.确保项目设计符合GMP及业务需求。Ensure facility and equipment designs meet GMP requirements and operational needs.2.2.设备技术管理 / Equipment & Technology Management编制及审核生产设备URS；Develop and review User Requirement Specifications (URS) for manufacturing equipment.参与关键生产设备选型及供应商评估；Support equipment selection and supplier evaluation activities.参与设备技术交流、设计审查及采购活动；Participate in technical discussions, design reviews, and procurement processes.推动设备需求与工艺需求有效结合。Ensure alignment between equipment capabilities and process requirements.2.3.FAT/SAT及验证支持 / Commissioning & Qualification Support 参与设备FAT、SAT及调试活动；Participatein Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), and commissioning activities. 支持设备DQ、IQ、OQ、PQ及CSV工作；Support Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Computer System Validation (CSV). 协助完成验证文件审核及问题关闭；Review qualification documentation and support issue resolution.2.4.无菌工艺支持/ Aseptic Process Support参与无菌工艺设计及优化;Participate in aseptic process design and continuous improvement initiatives.支持污染控制策略（CCS）建立；Support the development of the Contamination Control Strategy (CCS). 参与APS（Media Fill）及PPQ准备工作；Assist in Aseptic Process Simulation (APS/Media Fill) and Process Performance Qualification (PPQ) readiness activities. 支持无菌保障体系建设。Contribute to the establishment of sterility assurance systems.2.5.投产准备/ Operational Readiness参与SOP编制及审核；Support the development and review of manufacturing SOPs. 参与操作及维护培训体系建立；Assist in establishing operator and maintenance training programs. 支持技术转移及新产品导入；Support technology transfer and new product introduction activities. 参与工厂运营准备及检查准备活动。Participate in operational readiness and regulatory inspection preparation.三、任职要求 / Qualifications3.1.教育背景 / Education本科及以上学历，制药工程、药学、生物工程等相关专业。Bachelor's degree or above in Pharmaceutical Engineering, Pharmacy, Biotechnology, or related disciplines.3.2.工作经验 / Experience5年以上无菌制剂行业经验；Minimum 5 years of experience in the sterile pharmaceutical industry. 具备无菌生产、工艺或设备管理相关经验；Experience in sterile manufacturing operations, process support, or equipment management. 参与过无菌生产线建设、扩建或重大改造项目；Participation in sterile manufacturing line construction,expansion, or major upgrade projects. 具备设备选型、FAT/SAT或验证经验。Experience in equipment selection, FAT/SAT, commissioning, or qualification activities.3.3.专业能力 /Technical Competencies 熟悉：无菌生产工艺（Aseptic Processing），无菌灌装系统（Filling Systems），隔离器（Isolator）或RABS技术，APS（Media Fill），GMP及EU GMP Annex 1要求，设备验证及生命周期管理。Aseptic Processing，Sterile Filling Systems，Isolator and/or RABS Technology，APS (Media Fill)，GMP and EU GMP Annex 1 Requirements，Equipment Qualification and Lifecycle Management3.4.优先条件 / Preferred Qualifications参与过无菌注射剂新工厂建设项目；Experience supporting the construction of a new sterile injectable facility.具有冻干生产线经验；Experience with lyophilization (freeze-drying) manufacturing operations. 具有FDA、EMA或NMPA检查经验；Experience supporting FDA, EMA, or NMPA inspections. 具有商业化项目投产经验；Experience in commercial manufacturing start-up or site launch activities.熟悉Commissioning & Qualification（C&Q）体系。Familiarity with Commissioning & Qualification (C&Q) methodologies. 具有高活性产品（High Potency Products）生产经验，熟悉隔离控制、职业暴露控制（OEB/OEL）及污染控制策略者优先。Experience inhighly potent product manufacturing, including containment strategies,occupational exposure control, and contamination control, is preferred.