职位概要(Job summary):
1. 支持微生物和化学实验室的相关工作，特别是负责微生物检验。
Support on the Microbiology and Chemical Lab related work, especially responsible for microbiology inspection.
2. 参与微生物和化学实验室的维护，如设备/耗材的采购，维护和文件更新。
Participation in the maintenance of microbiology and chemical laboratory, such as equipment/consumables purchase, maintenance and document update.
3. 负责微生物和化学实验室的相关检验，如生物负荷测试，TAL/LAL测试，无菌测试，EO/ECH残留，工艺用水等。
Responsible for microbiology and chemical laboratory related inspection such as bioburden test, TAL/LAL test, Sterility test, EO/ECH residuals, Process water and etc.
4. 负责清洁区域/房间的日常监测。
Responsible for routine monitoring of clean areas/rooms.

工作职责(Responsibilities):
1、负责微生物和化学实验室检测相关工作，包括：准备实验用品、环境清洁/消毒、检测仪器清洁、微生物检测、化学检测、实验废弃物处理、检测记录和报告等；
Responsible for microbiology and chemical laboratory testing related work, including: preparation of inspection, environmental cleaning/disinfection, test equipment cleaning, microbiological testing, chemical testing, experimental waste disposal, completion of testing records and reports;
2、负责洁净区域（生产车间/实验室）的环境监测，检测项目包括：温湿度、压差、换气次数、尘埃粒子、沉降菌、浮游菌、表面微生物等；
Responsible for environmental monitoring of clean areas (production workshops/laboratories), including temperature and humidity, pressure differential, air exchange times, air particles, settling microbe, airborne microbe, surface microorganisms, etc.;
3、负责实验用水和工艺用水的抽样和检测，检测项目包括但不限于：微生物限度和细菌内毒素；
Responsible for sampling and testing of experimental water and process water, including but not limited to: microbiology limits and bacterial endotoxins.
4、负责无菌医疗器械产品的抽样和检测，检测项目包括生物负载、细菌内毒素、无菌、EO/ECH残留；
Responsible for sampling and testing of sterile medical device products, including bioburden, bacterial endotoxin, sterility, EO/ECH residues;
5、协助完成相关验证工作，包括但不限于：洁净空调系统验证、灭菌验证、清洁验证、消毒验证、检测方法学验证等。
Assist to complete related validation work, include but not limit to: clean room/HVAC system validation, sterilization validation, cleaning validation, disinfection validation, test method verification/validation, etc.
6、负责实验室的维护工作，包括：实验室的日常清洁、实验耗材的购买、实验仪器的维护保养及校验、文件记录/标签标识的管理和存档等。
Responsible for the maintenance of the laboratory, including: daily cleaning of the laboratory, purchase of consumables, maintenance and calibration of Lab instruments, management and archiving of documentation/label identification, etc.

任职资格(Qualification) :
1、大专及以上学历，微生物学、药学或其他相关专业。
College degree or above, such as microbiology, pharmacy or other related majors.
2、三年以上微生物检验实操工作经验；有丰富的微生物实验室及相关微生物测试和方法学验证经验；在无菌产品控制和多种灭菌技术（环氧乙烷、湿热）应用等方面有相关实践经验。
At least 3 years working experience in microbiological test. Solid experience in microbiology lab and related microbiological test & method validation, Relevant practical experience in sterile product control and utilizing multiple sterilization technologies; Ethylene oxide and moist heat.
3、具有解决问题的能力和较强的沟通能力(书面和口头)；良好的英语读写能力。
Have effective problem-solving abilities and strong communication stills (both written and oral). Good in English reading and writing skills.
4、积极主动，可靠，注重细节。
Proactive, dependable, detail oriented.

其他信息

行业要求：全部行业
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