The Biotools Maintenance Technician will be responsible for providing assembly machine technical support to Biotools Manufacturing Operations. The Biotools Maintenance Technician will execute all maintenance, calibration and troublshooting activities in support of production in a safe, cost-effective and environmentally sound manner, assuring capacity and achieving plant performance metrics.
Duties & Responsibilities
Equipment consists of automated assembly machines, moulding machines, pick and place systems, packaging equipment, inspection equipment, testing equipment, and support utilities in a cleanroom environment
· Responsible for setting up the assembly machines to produce the products to the specified quality standards
· Complete the necessary documentation associated with each lot
· Perform Preventive Maintenance tasks per defined schedules
· Make all necessary repairs to the area equipment
· Ensure all equipment is maintained to the highest level and all repairs both internally and externally are inspected and accepted.
· Complete trouble-shooting for all equipment and related issues.
· Represent the Maintenance team with regards to 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 in which maintenance capability should be improved (areas of focus to include technology understanding and problems solving techniques), lead improvement in these capabilities and reduce dependence on external resources.
· Ensure that all maintenance activities meet all the regulatory standards (e.g. FDA, HSA, ISO)
· Provide input into, and assist in the completion of, OPEX (Operational Excellence) 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 scientific risk-based approach to identifying key critical spares for plant and equipment and ensure that critical spares are in stock or are always readily available. Ensure that an effective program is then maintained.
· Responsible for carrying out calibrations at the required intervals according to the device listing and completing the relevant documentation
· Perform all tasks with due recognition of safety, environment, GxP & plant procedures.
· Trains new Technicians and production personnel on relevant equipment
· Works closely with project group to identify and implement machine improvement.
· Assist with EHS investigations and issue resolution
· Assists with process improvement work in the department.
· Assists with validation work in the department, including completion of trials & DOE’s.
· Assists with resolutions of major technical issues with equipment.
· Administration work related to duties such as placing POs, liaising with vendors and contractors.
Education
Relevant Mechanical trade or Engineering qualification
Work Experience
· 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
