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Job Description
Job Summary: Process engineer responsible for tool introduction, design, and debugging, as well as IQ, OQ, and PQ validation, in a high-volume moulding environment.
Responsibilities:
- Process Introduction of New Tools: Trial and qualification of tools at tool makers and in-house, tool set-up, and handover to production.
- Design and Debugging: Assist in the design and debugging of new systems, tooling, and automation.
- Validation Reports: Complete IQ, OQ, and PQ validation reports.
- Process Improvement: Perform designed experiments to enhance processes, improve yields, and reduce cycle times.
- Liaison: Front-line liaison with customers, suppliers, and toolmakers.
- Moulding Process Systems: Responsible for the Moulding Process Systems, including setting sheets, process control, and deviation control.
- Troubleshooting: Troubleshoot and support Team Leaders as required.
- Collaboration: Liaise with tool room, maintenance, production, and quality on a daily basis.
- Maintenance Programs: Develop and implement maintenance programs for moulding and ancillary equipment.
- Work Environment: Assist Team Leader and Line Coordinators in maintaining a clean and safe working environment.
- Compliance: Ensure ongoing compliance with GMP in all practices, recording of events, and processes.
- Training: Ensure compliance with all learnings from GMP training events.
Job Specifications:
- Education: Degree in Polymer or Mechanical engineering or equivalent.
- Experience: 3-5 years' experience in a high-volume moulding environment.
- Cleanroom Procedures: Experience in cleanroom procedures and medical moulding.
- Process Set-up and Validation: Familiar with process set-up and validation, including performing process window studies, IQ, OQ, and PQ.
Skills and Attributes:
- Teamwork: Ability to work in a team environment.
- Communication: Excellent organisation, communication, computer, and presentation skills.
- Troubleshooting: Systematic troubleshooting skills.
- Leadership: Strong leadership of technical issue resolution.
- Lean Six Sigma: Lean Six Sigma skills an advantage.
- Software: Proficient in MS Office applications, MS Project.
- Process Setup: SIM/RJG process setup an advantage.