SteriPack Group Hiring! Full Time Process Engineer in Selangor - Ricebowl

The Process Engineer is responsible for managing all qualification activities related to process equipment/ jig/ fixture/ tooling used by Production and all process improvement activities related to Production processes for our Medical Device/Pharmaceutical sector.

Key Responsibilities:

• Review and update routing and product structure related to Production processes.
• Analyze unplanned downtime for process equipment/ jig/ fixture/ tooling used by Production and propose improvement plan.
• Manage co-ordination activities with vendor related to process equipment/ jig/ fixture/ tooling used by Production and to make necessary arrangements when vendor is required to work onsite.
• Collaborate with NPI on process development for new projects and qualification of new process equipment/ jig/ fixture/ tooling.
• Analyze and lead investigation activities initiated from non-conformances related to Production processes.
• Lead troubleshooting and/ or testing activities on process equipment/ jig/ fixture/ tooling when requested by Production.
• Lead Production process improvement activities and manage the required activities till they are successfully implemented and transferred to Production.
• Update and maintain relevant documents / recording system related to process equipment/ jig/ fixture/ tooling, in line with current practice and QMS requirements.
• Responsible in the preparation works for audit or onsite visit/ tour.

Key Requirements:

• Degree level education in Engineering or Science or equivalent
• Minimum 2 years’ working experience preferably in the related field in manufacturing or medical industry.
• Knowledge of ISO 13485 and GMP is an advantage.
• Able to lead and work in a team with minimum supervision
• Good written and spoken English and Bahasa Malaysia.
• Computer skill – familiar with Microsoft Office.

Are you ready to make that career shift? Trust us, this role is always on-demand and you will grow a great portfolio with us.