生产工艺工程师

Working for the manufacturing department, Manufacturing Process engineer will be responsible for the following but not limited to：

在生产部工作，生产工艺工程师将负责以下但不限于

1.Responsible for leading the operation and training of the Lyophilizers；

负责带领操作和培训使用冻干机；

2.Preparation, review and implementation of SOPs and protocols；

编制，审查和执行SOP及方案计划；

3.Participate in all the operation of the Lyophilizers including CIP, SIP, setup and parts change over；

参加所有冻干机的操作，包括CIP,SIP，设置和部件更换；

4.Assist with the set up, and operation activities of the Cleanroom Isolators；

协助洁净间隔离器的设置和操作活动；

5.Support engineering department with relevant data for improving equipment efficiency and productivity；

为工程部提供相关数据以提高设备的效率和生产率；

6.Assist management during investigation reports.

协助管理层进行调查报告；

7.When required participate in the Weekly Operations Organization Meeting；

如有需要，参加每周的运营组织会议；

8.As required, participate in the Clean / sanitize filling areas / room spaces；

根据要求，参与清洁/消毒灌装区域/空间工作；

9.Set up the filling equipment / format parts in accordance with the batch records；

根据批记录设置灌装设备/格式零件；

10.Undertake aseptic simulations of the filling process according to procedures.

按规程进行灌装过程的无菌模拟；

11.Undertake line clearance of the filling areas / room spaces；

承接灌装区域/房间空间的生产线清洁；

12.Complete batch records for the filling process as each step is completed；

完成每一步的灌装过程的完整的批记录；

13.Support the routine preventative maintenance of the filling equipment；

支持灌装设备的日常预防性维护；

14.Support the non-routine maintenance of the filling equipment；

支持灌装设备的非日常维护；

15.Support filling equipment qualification, validation and revalidation.

支持灌装设备确认、验证和再验证。

16.Complete any other tasks assigned by supervisor or manager.