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职位信息

职位信息
配液工程师
Apr 16, 2021
配液工程师
中国
Wuxi
工作职责:
  • 负责物料的领取及传递工作,包括但不限于领、退料及物料的擦拭与消毒/Be responsible for the receiving and transferring of materials, including but not limited to receiving, returning materials, and disinfecting materials through wiping;
  • 负责配液前的准备工作,包括但不限于产品化冻观察、设备的日常校准、一次性袋子的装配、取样器具准备或样品标签打印/Be responsible for preparation before formulation, including but not limited to product thawing observation, daily calibration of equipment, assembly of disposable bags, preparation of sampling equipment or sample label printing;
  • 负责生产过程中的配液操作,包括但不限于配液系统操作、管路连接、辅料称量及稀释液配制、容器敞口投料、取样、DS转移及搅拌、中控样品检测;熟悉一次性配液系统、天平、蠕动泵、pH计、电导率仪等设备的工作原理及操作方法/Be responsible for formulation operation, including but not limited to formulation system operation, pipeline connection, auxiliary material weighing and dilution formulation, feeding through feeder nose, sampling, DS transfer and mixing, IPC test ; familiar with the working principles and operating methods of equipment such as disposable formulation system, balance, peristaltic pump, pH meter, conductivity meter, etc;
  • 负责生产结束后的房间或设备清洁,记录填写及协助QA完成清场放行/Be responsible for cleaning the room or equipment after production, filling in records and assisting QA to complete the clearance and release;
  • 负责工作区域内的SOP起草,培训及更新,包括但不限于人、物流SOP,操作类SOP;实时关注法规对配液的最新要求,更新SOP等文件;根据SOP,完成标准MBR模板的撰写与维护/Be responsible for the drafting, training and updating of SOP in the work area, including but not limited to personal and material flow SOP, operational SOP; following to the latest regulatory requirements for liquid dispensing to update SOP and other documents;, completing standard MBR templates writing and maintenance according to SOP;
  • 负责设备的日常维护,包括但不限于设备校验或维保/Be responsible for the daily maintenance of equipment, including but not limited to equipment verification or maintenance;
  • 负责配液区域的房间定置及管理(5S)/Be responsible for fixed location and management in the formulation area (5S)
  • 参与车间其他生产活动/Take part in other production activities of the facilities;
  • 具备一定的变更或偏差撰写经验,参与过变更实施或偏差调查及改进/Have some experience in writing change or deviation, and have participated in change implementation or deviation investigation and improvement;
  • 完成主管安排的其它工作/Complete tasks assigned by line manager;
  • 参与项目文件审核及签批流程,跟踪及反馈审核意见,推进文件签字进度/Take part in the review and approval of project docs, track and feedback the comments and push the docs signing;
  • 参加DP4相关生产工艺设备设计及验证活动。负责配液工艺设计,评估。负责配液相关偏差调查/Assist in design and validation of DP4 process equipment. Responsible for formulation process design and assessment. Responsible for formulation related deviation investigation.
任职能力:
  • 药学、药物制剂学、微生物学、生物或化学工程或相关专业本科及以上学历。本科毕业具备3三年及以上工作经验。硕士毕业具备2年及以上工作经验/Bachelor degree or above in pharmacy, pharmaceutical preparation, microbiology, biological or chemical engineering or related field.Bachelor degree with 3 years or above working experience.Master degree with 2 years or above working experience.
  • 具备GMP洁净区生产操作经验,有无菌溶液配制或灌装经验为优,熟悉大分子蛋白类产品溶液配制的重点和质量控制要求。能根据生产工艺制定CQA/Have manufacturing experience in GMP hygiene area and better in formulation preparation or filling operation; Familiar with the key points and quality control requirements of antibody product formulation preparation.
  • 具备不锈钢配液系统或一次性搅拌系统操作经验/Have experience in disposable formulation mixer system.
  • 具备精益运营理念,持续性改善,脆弱点识别并改善意识/Lean awareness, continuous improvement and vulnerabilities identification and improve capability.
  • 具备项目管理或协调经验/Project management or coordination experience.
  • 具备良好的英语读写能力,能使用英语进行熟练沟通交流/Good in reading and writing of English, able to communicate in English.
  • 熟练使用计算机/Good skills in using computer.
  • 有较强的分析问题能力及良好的沟通技巧,工作认真、细致,具有良好的团队合作精神/Excellent ability in analysis, communication skills and problem-solving. Work hard and carefully with strong team cooperation ability.
  • 能接受倒班以及夜班/Accept shift work and night shift.
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