DP 8-制剂生产助理工程师

无菌生产操作 负责无菌制剂生产相关工作，包括配液、灌装、灯检、贴签等生产操作。 Aseptic Manufacturing Operations Perform aseptic drug product manufacturing activities, including solution preparation, filling, visual inspection, and labeling operations. 设备操作与维护 负责生产设备的操作、日常维护，并配合设备维修、校验及验证工作，确保设备处于良好运行状态。 Equipment Operation & Maintenance Operate manufacturing equipment, perform routine maintenance, and support equipment repair, calibration, and

activities to ensure reliable equipment performance. 生产文件管理 负责批生产记录、设备使用台账及相关生产文件的填写、审核与管理，确保生产记录真实、完整、可追溯。 Production Documentation Management Complete, review, and maintain batch production records, equipment logbooks, and related manufacturing documents, ensuring accuracy, completeness, and traceability. 洁净区与物料管理 负责洁净区的清洁、消毒及生产物料管理，确保生产环境和物料状态符合GMP要求。 Cleanroom & Material Management Perform cleanroom cleaning and disinfection activities and manage production materials to ensure compliance with GMP requirements. EHS与合规执行 严格遵守GMP、EHS、数据完整性及公司相关管理要求，确保生产活动符合质量、安全及合规标准。 EHS & Regulatory Compliance Adhere to GMP, EHS, data integrity, and company compliance requirements to ensure safe, compliant, and high-quality manufacturing operations. 任职要求 Qualifications 教育背景 制药、生物工程、药学等相关专业专科或本科毕业；应届毕业生或具有2年以上制药行业相关工作经验。 Education Associate or Bachelor's degree in Pharmaceutical Sciences, Biological Engineering, Pharmacy, or other related disciplines. Fresh graduates are welcome to apply; candidates with more than 2 years of relevant experience in the pharmaceutical industry are preferred. 专业经验 了解无菌制剂生产工艺，有无菌药品生产经验者优先。 Professional Experience Basic knowledge of aseptic drug product manufacturing processes; experience in sterile pharmaceutical manufacturing is preferred. 设备知识 了解无菌制剂生产设备。 Equipment Knowledge Knowledge of aseptic manufacturing equipment. 团队协作能力 具备较强的责任心、执行力和团队协作能力，能够适应生产现场工作节奏。 Teamwork & Execution Demonstrate a strong sense of responsibility, effective execution capability, and excellent teamwork skills in a manufacturing environment. 办公软件技能 熟练使用Office等常用办公软件，能够完成生产记录、数据整理及相关文件编制工作。 Computer Skills Proficient in Microsoft Office and other standard business applications, with the ability to complete production documentation, data management, and related record preparation. 综合能力 工作认真细致，具备良好的沟通能力、学习能力和问题解决能力，能够在GMP环境下高效开展工作。 Core Competencies Detail-oriented with strong communication, learning, and problem-solving skills, and capable of working effectively in a GMP-regulated environment.