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Process Engineer

4 weeks ago

Klang, Selangor, Malaysia SteriPack Group Full time

We are hiring a highly dedicated Process Engineer who will be 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.

Job 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 plans.
  • Manage coordination activities with vendors related to process equipment/jig/fixture/tooling used by Production and make necessary arrangements when vendors are 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 until they are successfully implemented and transferred to Production.
  • Update and maintain relevant documents/recording systems related to process equipment/jig/fixture/tooling, in line with current practice and QMS requirements.
  • Responsible for the preparation works for audits or onsite visits/tours.
Job 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 skills – familiar with Microsoft Office.

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

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