The NPI Technician is responsible for provision of technical support to New Product Introduction teams. Working closely with NPI Engineers, the NPI Technician is proficient in process setup and optimization, design and provision of tooling, jigs and fixtures and in the development and implementation of test methods. The NPI Technician maintains accurate records of process development studies in addition to compliance with guiding NPI and GMP procedures.
Principal Duties and Responsibilities:
- Develop process parameters for optimisation of equipment and process. Execute process development and optimization activity including range studies, work as directed by the NPI engineers.
- Collect and collate process data and execute basis statistical analysis of process related data in support of ongoing process optimization activity. Present such data in an organised format for review by extended team members.
- Develop Subject Matter Expertise ( SME) knowledge level for process technologies for which you are responsible.
- Define requirements and source, purchase and install, jigs, fixtures and tooling required to support NPI project schedule. Liaise with tooling, equipment and service suppliers or contractors to identify solutions to customer needs or as defined by the NPI engineer
- Install and commission new equipment in accordance with quality systems requirements.
- Complete documentation as required by NPI and quality system procedures. Complete Technical reports. Develop and document test methods. Draft and release production or maintenance procedures as required.
- Build customer and engineering samples including inspection and testing as assigned.
- Support innovation culture by participation in customer and supplier visits, design brain storming meetings and customer project discussions.
- Support efficient transfer to production by creation of training plans, training materials and training of other technical resources and POA’s during production handover.
- NPI Technicians should have completed a craft apprenticeship in tool making, electrical or equivalent. Alternatively the NPI Technician will have an NCEA Certificate or Diploma in engineering followed by 2- 3 years relevant practical experience.
- A minimum of 5 years in a production or development environment including at least 3 years medical device/pharmaceutical and/or diagnostics manufacturing experience is desirable.
- Must have a good working knowledge of quality systems as they apply to the engineering and NPI areas. Self starter with good inter-personal skills. Practical level-headed individual who is prepared to actively participate as an active member of the team.
- The ability to troubleshoot process and equipment in a logical manner to resolve the issues.