- Assists in the development and implementation production/processing methods and controls to meet quality standards in the most efficient manner for new and existing moulding processes. Monitors the molding process; troubleshooting problem processes and assists in the resolving quality issues.
- Key Responsibilities and End Results:
- Process Introduction of New Tools; Tool trials at tool makers and in-house, tool set-up, qualification runs and handover to production.
- Assist with the design and debugging of new systems, tooling and automation.
- Completion of IQ, OQ, PQ validation reports.
- Perform designed experiments to enhance processes as well as improve yields and utilization through reduced cycle and efficient set-ups.
- Front line liaison with customers, suppliers and toolmakers.
- Responsible for the Moulding Process Systems including setting sheets, process control, deviation and control of setting sheets.
- Troubleshooting, supporting Team Leaders as required.
- Liaising with tool room, maintenance, production and quality on a daily basis.
- Develop/Implement maintenance programs for moulding and ancillary equipment.
- Assist Team Leader and Line Coordinators in maintaining clean, safe working environment.
- Support all company safety and quality programs and initiatives.
- Ensure ongoing compliance with GMP in all practices, recording of events and processes.
- Ensure compliance with all learnings from all GMP training events.
- Other responsibilities may be assigned from time to time as needed, based on the evolution of the company and the requirements of the department/position.
- Job Specifications:
- Degree in Polymer or Mechanical engineering or equivalent.
- 3-5 years’ experience in a high volume moulding environment.
- Experience in cleanroom procedures and medical moulding.
- Familiar with process set up and validation, including performing process window studies, IQ,OQ,PQ highly desirable.
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