Key Accountabilities
The Maintenance Technician plays a crucial role in supporting the production process at Biotools Manufacturing Operations by providing assembly machine technical assistance.
Duties and Responsibilities:
* Equipment encompasses automated assembly machines, moulding machines, pick and place systems, packaging equipment, inspection equipment, testing equipment, and support utilities within a cleanroom environment.
* Responsible for setting up assembly machines to produce products that meet specified quality standards.
* Complete necessary documentation associated with each lot.
* Perform preventive maintenance tasks according to defined schedules.
* Make all necessary repairs to area equipment.
* Ensure all equipment is maintained at the highest level, with all repairs inspected and accepted both internally and externally.
* Complete trouble-shooting for all equipment and related issues.
* Represent the Maintenance team regarding safety initiatives and practices to develop and maintain an injury-free workplace.
* Work within a larger engineering team of mechanical and electrical resources, including automation, facilities, project, and system engineers, with emphasis on performance, involvement, teamwork, and personal development.
* Utilize the existing CMMS system (SAP NEXT) to ensure all maintenance activities through consistent application of a work order system.
* Identify areas where maintenance capability should be improved, lead improvement in these capabilities, and reduce dependence on external resources.
* Ensure all maintenance activities meet regulatory standards (e.g. FDA, HSA, ISO).
* Provide input into, and assist in the completion of, OPEX projects to improve automation, reduce lead-time, and reduce EHS risks in the department.
* Reduce equipment downtime and increase efficiency of machine changeovers.
* Identify, develop, and implement projects in the areas of efficiency improvement, scrap reduction, product quality improvement, cost reduction, safety, etc.
* Develop a scientific risk-based approach to identifying key critical spares for plant and equipment, ensuring critical spares are in stock or readily available. Ensure an effective program is then maintained.
* Responsible for carrying out calibrations at required intervals according to device listing and completing relevant documentation.
* Perform all tasks with due recognition of safety, environment, GxP, and plant procedures.
* Train new technicians and production personnel on relevant equipment.
* Work closely with project groups to identify and implement machine improvements.
* Assist with EHS investigations and issue resolution.
* Assist with process improvement work in the department.
* Assist with validation work in the department, including completion of trials and DOE's.
* Assist with resolutions of major technical issues with equipment.
* Administration work related to duties such as placing POs, liaising with vendors and contractors.
Requirements:
* Minimum of 3-5 years working in a Medical Device or Pharma manufacturing environment.
* Working experience of automated production assembly machines.
* Working knowledge of electrical and electronic systems.
* Demonstrated high-performance history, proven ability to execute, and get results.
* Ability to work with employees at all levels of the organisation.
* Preferable experience with CMMS SAP NEXT PM System.
* Preferable experience with a Calibration System.
* Preferable experience with moulding machines and mould tools.
* Working experience with planned Preventative Maintenance approaches.
* Excellent awareness and experience in relation to Quality and Environmental Health and Safety.
* Relevant Mechanical trade or Engineering qualification.