Process Engineer

Ensera Group; Klang City; On-site; MYR 44,640 - 66,960; Full time

Job summary

A leading manufacturing company in Klang City is seeking a Process Engineer to manage qualification activities for production processes. The successful candidate will analyze equipment-related downtimes, coordinate with vendors, and lead process improvements. Applicants should have a degree in Engineering or Science, at least 2 years of experience in the manufacturing or medical industry, and proficiency in ISO 13485 and GMP standards. Strong leadership and communication skills are essential for this role.

Qualifications

• Minimum 2 years’ working experience in manufacturing or medical industry.
• Knowledge of ISO 13485 and GMP is an advantage.
• Good written and spoken English and Bahasa Malaysia.

Responsibilities

• Review and update routing and product structure related to Production processes.
• Analyze unplanned downtime and propose improvement plan.
• Manage coordination activities with vendors for process equipment.

Skills

Leadership

Problem-solving

Communication

Analytical skills

Education

Degree in Engineering or Science

Tools

Microsoft Office

Job description

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.

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