KEY ACCOUNTABILITIES:
1. 制剂生产设备(洗烘灌轧和冻干机及自动进出料,隔离器)日常维护、预防性维护、现场紧急维修及停产维护保养,备品备件的管理
Responsible for the daily maintenance, preventive maintenance, on-site emergency maintenance and off-production maintenance, spare parts management for the equipment in the drug product workshop. The equipment contains washing machine, sterile tunnel, filling machine, capping machine, lyophilizer and the automatic loading/unloading machine,Isolator.
2. 负责设备日常点检及预防性维修保养,并及时记录在Maximo系统中。
Responsible for daily inspection and preventive maintenance for equipment and record that in Maximo system.
3. 为工艺设备调试/确认及验证工作提供支持
Provide support for process equipment commissioning/qualification and validation
4. 针对设备存在的问题,提出改进方案.
Provide improvement plan for equipment which have some issues.
5. 根据设备情况,提出合理的备件采购建议.
According to the equipment situation, provide suggestions on spare parts procurement
6. 组织对已有设备进行工程分析,对设备进行不断的改善,持续改进设备运行状况、运行效率、人机工程,推进成本节约
Organize engineering analysis for current equipment, continuously improve the equipment, continuously improve the operating status, operating efficiency, ***-machine engineering, and promote cost saving.
7. 负责编写及更新工艺设备维护SOP文件
Responsible for writing and updating SOP documents for process equipment maintenance
8. 参与相关偏差调查,与其他部门保持沟通,不断发现新的改进机会
Participate in deviation investigation, maintain communication with other departments, and constantly find new improvement opportunities
9. 及时真实做好运行记录、维修记录、保养记录等并归档,对设备运行数据进行整理及分析,解决设备出现的各种故障,减少设备的停机时间,降低设备故障率;
Timely filing of operation records, maintenance records, maintenance records, etc., sorting out and analyzing equipment operation data, solving all kinds of equipment failures, reducing equipment downtime and reducing equipment failure rate.
10.上级主管交办的其他工作。
Complete other tasks arranged by company supervisor.
REQUIREMENTS:
1. 从事过与岗位职责相似的工作,有电子厂或制药厂相关岗位经历者优先考虑;
Have experience on similar job responsibility, with experience in electronic factory or pharmaceutical factory is preferred.
2. 有电工证、焊工证、压力容器证之一,能够操作氩弧焊的优先考虑;
At least have one of the electrician license, welder's certificate and pressure vessel certificate. The ability of electrical and argon arc welding is preferred.
3. 良好的团队合作和语言表达能力,积极向上的自我进取精神;
Good teamwork and language skills, positive self-enterprising spirit.
4. 具备较好的理解能力、学习能力、沟通能力、发现问题、分析与解决问题的能力;
Good comprehensive ability, learning ability, communication ability, good ability for finding issues, analyzing issues and solving issues.
5. 具备较强的设备故障隐患分析和动手能力,同时也应具备良好的沟通能力;
Good troubleshooting and hand on ability for equipment, good communication ability.
EDUCATION (Indicate the mini. requirement & preferred discipline):
大专文化程度,制药、机械、机电一体化专业的优先考虑;
Full time college degree or above, pharmaceutical, machinery and mechatronics major is preferred.
OTHER SKILLS, ABILITIES & EXPERIENCE:
经历过GMP认证工作,有FDA cGMP或EU GMP认证经历者更佳
Experienced the GMP certification, the FDA cGMP or EU GMP certification experience is preferred.