Responsible for set-up, troubleshooting and monitoring of equipment in Production, Pilot Plant, and Test Lab. Support basic equipment qualification, maintenance and calibration activities with record keeping.
- Trouble-shoot, repair and test production equipment.
- Update equipment records in RAM or other record keeping system.
- Routinely monitor production equipment. Adjust equipment setting parameters to optimize equipment performance.
- Assist equipment/parts ordering, receiving and locating to the designated area.
- Assist and conduct equipment IQs, minor PMs, and calibrations.
- This position assumes and performs other duties as assigned.
- Daily set up and shut down production equipment such as plasma stations, ISOPStat lines, etc. that may be manual, semi-automated or fully automated
- Assemble, test and maintain fixtures, modules, and replacement parts.
- Experience with process transfers, process validation, and health authority inspections
- Thorough understanding of current Good Manufacturing Practices (cGMPs) and they apply to process operation and process control
- Experience in high volume medical device manufacturing, including scale-up/scale down and in commercial setting
- Need to be very familiar with MS Excel, Word, PowerPoint, etc.
- Require more than 3 year of experience with equipment assembly and manufacturing
- Experience in an equipment maintenance position
Vacancy Type: Full Time
Job Location: Simpang Ampat, Penang, Malaysia
Application Deadline: N/A