Microbiological Engineer

Lab / Testing Routine Works 实验/测试日常工作 – 80%

• Strictly follow lab operation procedure for testing/inspection, record, calculation, justification and ensure data integrity. And comply with the corporate/ISO/regulation/Customer requirements.

严格按照实验室操作程序进行测试、记录、计算、判定并确保数据的完整性。并符合公司/ISO/法规/客户的要求。

• Responsible for BI sterility test/bioburden test/Product sterility test EO residual test etc.

负责BI无菌测试/生物负载测试/产品无菌测试/环氧乙烷残留测试等。

• Responsible for testing per procedure conduct data analysis and archive.

负责按文件要求进行各项检测，对测试结果进行数据分析和归档。

Lab Quality Assurance实验室质量保证 – 10%

• Responsible for lab deviation investigation perform corrective and preventive actions.

负责实验室偏差分析及调查，执行纠正预防措施。

• Assist Manager for lab procedure maintenance and update accordingly.

协助经理维护和更新实验室文件。

• Assist in lab related internal and customer audit and plant quality system audit.

协助实验室内部和客户审核及工厂质量体系审核。

Others 其他工作 – 10%

• Responsible for equipment calibration validation and routine monitor/maintenance.

负责设备校验，验证和日常监控/维护。

• Strictly follow lab safety and 5S requirements. Responsible to ensure that all the laboratory is clean and tidy all the time.

严格遵守实验室安全和5S规定。确保实验室洁净整齐的状态。

• Other work required by Manager.

经理安排的其他工作。

• Bachelor degree in microbiology or related science or College degree with more than 5 year related working experience. 微生物学或相关专业本科学位，或大专学历（5年以上相关微生物实验室工作）；
• At least 3 years relevant laboratory experience in medical or related industry.

在医药、医疗器械或相关行业的实验室工作3年以上；