The Biotools maintenance technician will be responsible for providing technical support to BioTools Manufacturing Operations. The candidate will execute all maintenance activities in support of production in a safe, cost-effective and environmentally sound manner, assuring capacity and achieving plant performance metrics.
- Equipment consists of Moulding machines, pick and place systems, packaging equipment, testing equipment, support utilities in a cleanroom environment
- Responsible for setting up the machines to produce the products to the specified quality standards
- Complete the necessary documentation associated with each lot
- Perform Preventive Maintenance tasks
- Make all necessary repairs to the machines
- Ensure all moulds are maintained to the highest level and all repairs both internally and externally are inspected and accepted.
- Complete trouble-shooting for all Moulding equipment and mould 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 (INFOR) 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, IMB, HSA, EPA)
- 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
- Helps with process improvement work in the department.
- Assists with validation work in the department, including completion of trials & DOE’s.
- Supports with resolutions of major technical issues with equipment.
- May be required to work some weekends to assist in on-going projects and validation.
- May be required to assist in providing shift cover if technical resources are low.
- Must be flexible with working hours if necessary.
- Travel as required to work on internal and external projects, e.g. transfers from other plants, new projects. Expected to be minimal
- Administration work related to duties such as placing POs, liaising with vendors and contractors
- Relevant mechanical trade or engineering qualification
- Qualification in Moulding highly desirable
- Minimum of 3-5 years working in a Med Device or Pharma manufacturing environment
- Working knowledge of electrical and electronic systems in a production environment
- Experience of injection Moulding processes
- 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 INFOR PM System;
- Preferable experience with a Calibration System
- Be familiar with planned preventative maintenance approaches
- Excellent awareness and experience in relation to Quality and Environmental Health and Safety
- Familiar with GMP requirements within a regulated industry.
- Effective verbal, written & interpersonal communication skills.
- The ability to work effectively within a team environment
- High level of energy and enthusiasm and the ability to energize others
- Keen to learn & take responsibility.
- Strong organisational, time management and planning ability.
- Computer Literate Excel, Word etc.
- Methodical Work Approach
- Willingness to work shift if required
- Willingness to work a reasonable amount of Overtime
For a confidential discussion and more information on the role, please contact Aisling Lane on 021-4320675 or email firstname.lastname@example.org