确认工程师

principle duties and responsibilities 
1、coordinate and perform eol process validation projects; 

2、redaction of validation master plan, validation protocols, and validation reports; 

3、lead risk assessment exercises in support of process validation activities; 

4、perform periodic reviews of validated process or reports; 

5、coordinate process validation ution between all involved departments; 

6、new eol process development and introduction; 

7、improvement of existing eol process; 

8、sop and work instruction development and improvement; 

9、others tasks assigned by supervisor. 

资格要求（教育、经验、知识、技能及资质等）expected areas of competence (i.e., education, experience, knowledge, skills and credentials) 
1 bachelor degree or above in engineering or science field; 

2 good english communication skill includes listening, speaking, reading and writing; 

3 2 years working experience minimum, in medical industry is preferred; 

4 familiar with qsm validation system, manufacturing procedures and quality standards; 

5 familiar with the validation lifecycle (iq-e, oq-e, oq-p, pq), and statistical analysis; 

6 good leadership, project management and communication skills. 

7 ability to effectively work at all levels of an organization.