Job Description
The Maintenance Technician plays a pivotal role in ensuring the smooth operation of Biotools Manufacturing Operations' assembly machines. This position demands exceptional technical expertise and problem-solving skills to execute maintenance, calibration, and troubleshooting activities safely, efficiently, and cost-effectively.
Duties & Responsibilities:
* Provide technical support for automated assembly machines, moulding machines, pick and place systems, packaging equipment, inspection equipment, testing equipment, and support utilities within a cleanroom environment.
* Ensure assembly machines operate within specified quality standards by setting them up correctly.
* Complete documentation associated with each production lot.
* Perform preventive maintenance tasks according to defined schedules.
* Maintain equipment to the highest level, repairing any damage as needed, and inspecting all repairs internally and externally.
* Troubleshoot equipment and related issues promptly.
* Represent the Maintenance team in promoting safety initiatives and practices to maintain an injury-free workplace.
* Collaborate with a multidisciplinary engineering team (mechanical, electrical, automation, facilities, project, and system engineers) to optimize performance, teamwork, and personal development.
* Utilize the CMMS system (SAP NEXT) to manage maintenance activities through consistent application of a work order system.
* IDentify areas for maintenance capability improvement, lead these improvements, and reduce dependence on external resources.
* Ensure maintenance activities meet regulatory standards (e.g., FDA, HSA, ISO).
* Contribute to OPEX projects to enhance automation, reduce lead-time, and minimize EHS risks in the department.
* Reduce equipment downtime and streamline machine changeovers.
* Develop and implement projects focused on efficiency improvement, scrap reduction, product quality enhancement, cost reduction, and safety.
* Implement a scientific risk-based approach to identifying key critical spares for plant and equipment, ensuring their availability and maintaining an effective program.
* Perform calibrations at required intervals according to device listings and complete relevant documentation.
* Recognize and adhere to safety, environmental, GxP, and plant procedures during all tasks.
* Train new technicians and production personnel on relevant equipment.
* Work closely with the project group to identify and implement machine improvements.
* Assist with EHS investigations and issue resolution.
* Participate in process improvement work in the department.
* Support validation work, including completion of trials and DOE's.
* Resolve major technical issues with equipment.
* Administer duties such as placing POs, liaising with vendors, and contractors.
Requirements:
* A minimum of 3-5 years of experience working in a Medical Device or Pharma manufacturing environment.
* Familiarity with automated production assembly machines.
* Working knowledge of electrical and electronic systems.
* Demonstrated high performance history, proven ability to execute and achieve results.
* Ability to work with employees at all levels of the organization.
* 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.