Job Summary
A 50-word summary of the job description: Develop and improve moulding process systems, troubleshoot issues, and ensure compliance with GMP in a high-volume moulding environment.
Key Responsibilities:
* Process Introduction of New Tools: Trial tools at manufacturers and in-house, setup, qualification runs, and handover to production.
* Design and Debugging: Assist in developing new systems, tooling, and automation.
* Validation Reports: Complete IQ, OQ, PQ validation reports.
* Experimentation: Conduct experiments to enhance processes, increase yields, and reduce cycle times.
* Liaison: Communicate with customers, suppliers, and toolmakers.
* Moulding Process Systems: Set up sheets, control processes, manage deviations, and set up control sheets.
* Troubleshooting: Identify and resolve problems, assist Team Leaders as needed.
* Daily Liaison: Work with tool room, maintenance, production, and quality teams.
* Maintenance Programs: Develop and implement maintenance programs for moulding and ancillary equipment.
* Clean and Safe Environment: Support Team Leader and Line Coordinators in maintaining a clean and safe working environment.
* Safety and Quality Initiatives: Participate in company safety and quality programs and initiatives.
* GMP Compliance: Ensure ongoing compliance with Good Manufacturing Practices (GMP) in all practices and processes.
Requirements:
* Bachelor's Degree in Polymer or Mechanical Engineering or equivalent.
* 3-5 years' experience in high-volume moulding environments.
* Familiarity with cleanroom procedures and medical moulding.
* Experience with process setup and validation, including process window studies, IQ, OQ, PQ.
Desirable Skills:
* Teamwork and collaboration.
* Excellent organisational, communication, computer, and presentation skills.
* Systematic troubleshooting skills.
* Strong leadership of technical issue resolution.
* Lean Six Sigma skills.
* Proficiency in MS Office applications and MS Project.
* SIM/RJG process setup skills.