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.
完成主管或经理安排的其他工作任务。