Maintenance Engineer : Permanent Days
Location: Birmingham, West Midlands
The Client: My client specialises in the research, development, manufacture and sale of innovative medical diagnostic products, instrumentation and materials
The Role: The post holder is responsible for operating, maintaining, fault finding and carrying out the changeover processes as required, on equipment used within the all areas of the facility. Ensuring that all relevant documentation is completed following the quality systems in accordance with the company quality policy.
Working with departmental management teams in ensuring equipment is available for use as required and issues are identified and actioned. This may require working with external suppliers and outside normal hours.
Principal Duties and Responsibilities
- To set up and shut down all equipment within the Filling area to support the daily production plan, in line with requirements.
- To perform all change over tasks in a timely manner to reduce the downtime between batch changes
- To perform all in-line process checks on the equipment and batches i.e. torque tests, fill volume checks, label checks etc. as detailed in the procedures and record as required.
- Perform all appropriate Preventative Maintenance activities.
- Perform with external assistance if required electrical installations, repairs, improvements and fault finding.
- To perform all first line fault finding on equipment when issues arise, ensuring manufacturing can resume compliantly and in a timely manner.
- Provide assistance to any Project Team on implementing changes to equipment
- Conduct any necessary validation/engineering activities supporting improvements.
- Assist in the training of operators in the correct operation of the equipment (not the set up/shut down) and ensure management has the correct details to update training records
- To ensure all necessary documentation is correctly completed in line with cGMP requirements
- To support any audits carried out in the department.
- To support any investigations as a result of product performance / complaints and any root cause analysis.
- Identify through data analysis improvements within the changeover process to reduce lost production capacity due to equipment availability
- Working with the departments management team, identify/support areas of improvement with the processes used within the Prepack area to continually improve the departments throughput i.e. standard times for processes, equipment, future investment, etc.
- Develop the procedures for each piece of equipment so that the set-up and shut down processes are: Clear, Logical, and Efficient.
- Develop check sheets which can become part of the batch DMR to include set up parameters, in-process checks etc. so that there is a consistent approach to this activity
- Write any necessary validation/engineering reports and ensure compliance to the Quality System process
- Update any assembly/equipment procedures as required ensuring cGMP processes are met.
- Liaise with any equipment suppliers to ensure equipment is repaired in timely manner either through telephone/online support or through attendance on site (this may include out of normal hours)
- Working with procurement and department management ensure all critical equipment has service contracts in place including Service Level Agreements (SLA) i.e. time to respond to issues on telephone or visit to site.
- To conduct any/all necessary Maintenance & Calibration (M&C) on equipment within the Production areas in accordance with the documented procedures (and suppliers guidelines) and within the timelines expected. If equipment fails it's M&C then to highlight immediately to department management and Quality and to support remedial actions.
- To be involved as required in new equipment definition to support the continued operation / expansion of all areas within the facility..
Knowledge and Skills required:
- Minimum engineering qualification - ONC, NVQ 3 or equivalent
- Engineering background within a liquid bottling environment or automated processing equipment would be ideal.
- Previous experience of working in a Quality System Environment : preferably within IVD medical Devices or similar.
- Electrical, Mechanical, Pneumatic maintenance.
- Machine installation, fault finding and repair
- Good organizational skills
- Excellent communication skills (written and verbal)
- Excellent negotiation skills (when working with others)
- Good analytical skills
- Computer literacy- Word, Excel, Office
- Time management
- Proven strong ethical standards
- Honest, trustworthy and discreet
- Hard working and determined to achieve
- Open to new ideas, an agent for change
- Empathetic, able to adapt style to achieve results
- Evidence of continuing personal development.
- Recognition that the role requires additional hours to be worked where necessary to meet deadlines and other needs.
- Experience in a Continuous Improvement environment to drive change
- Project management skills
To apply for this role please submit your latest CV or contact Aspect Resources on 0121794 8181