The Project Equipment Technician is key member of engineering team that is tasked with delivering innovative, automated manufacturing equipment which is designed to meet the future business and capacity needs of the Cork site. The role involves supporting the equipment design, build and validation stages of the project by providing valuable input which ensures key milestones are successfully achieved. The Project technician will lead activities such as; setting up the equipment following installation, maintaining and calibrating the equipment throughout the equipment lifecycle and actively participating in process development work.
DUTIES AND RESPONSIBILITIES:
Engineering Project & New Equipment Introduction's
- Work closely with engineering group on specific Process & Equipment Projects.
- Represent the Maintenance function on the introduction of all new equipment into the department.
- Compile and ship raw material components for vendor use.
- Develop a list of component defects for potential use in designing appropriate automated vision systems.
- Actively participate in equipment design reviews, build inspections, FAT, SAT, commissioning, validations etc. (overseas travel will be required < 15%). Ensure all the relevant validation documentation is accurately completed.
- Timely close-out of any validation deviations which may have been encountered.
- Prepare the maintenance systems to be ready for the new equipment – INFOR PMs, CALs, Spares, Maintenance SOP’s.
- Become the system and process expert on the new equipment, ensuring equipment metrics are achieved (emphasis and expertise required at design stage to ensure project success).
- Develops a strong product knowledge and pass this knowledge on to the relevant dept technicians.
- Support the new equipment during initial ramp up.
- Train the other technicians in the new equipment.
- Responsible for commissioning and setting up all new Moulding, Overmoulding, Assembly, Packaging & Test equipment to manufacture products to the specified quality standards.
- Ensures equipment installation and commissioning is in compliance with GMP and site safety rules.
- Makes all necessary repairs to the equipment during the project in conjunction with the manufacturers recommendations.
- Takes a lead role with identifying appropriate resolutions of major technical issues with equipment.
- Responsibility for organising contractor visits on-site for specific maintenance or calibration requirements.
Process Development & Improvement Skills:
- Participate in initial process development activities at vendor site i.e. Moulding, Membrane Heat Sealing, Ultrasonic Welding, Air Integrity testing etc.
- Support process optimisation using statistical means (i.e. Minitab software) as equipment build progresses to completion.
- Ensure robust process parameter windows are established prior to FAT execution.
- Confirm process parameter windows following equipment transfer to Cork site.
- Responsible for the ongoing identification, development and implementation of projects in the areas of:
- OEE improvement.
- Scrap reduction.
- Product quality improvement.
- Cost reduction.
- Safety enhancement.
Engineering Administration/ Spares/ Documentation:
- Identifies and maintains a comprehensive list of spares for the relevant dept. for inclusion into the MRO system.
- Compile the required information & documentation i.e. specific vendor component manuals with respect to PM’s and calibrations for introduction of the line into Infor EAM.
- Responsible for drafting equipment preventative maintenance schedules and submitting into INFOR.
- Responsible for reviewing and updating any quality documentation from an equipment perspective. Provides valuable input into critical documents such as MP, SOP, GMP permit, validation protocols/reports etc.
- Responsible for identifying, reporting and closing potential EHS incidents associated with the new equipment introduction.
- Responsible for ensuring that the new equipment achieves the OEE & Output metrics.
- Reviewing equipment manuals for accuracy prior to vendor release.
- Responsible for working closely with material and equipment suppliers to develop the appropriate specification requirements.
- May be required to work weekends to assist and support the project as necessary.
- Must be flexible with working hours when required. Overtime and/or Shift work may be required at times throughout the project to ensure key milestones are met.
- During different intervals within the project duration or between projects you may be required to assist departments in maintenance activities.
- Engineering or Science Certificate/Diploma at minimum or relevant time-served trade.
- 5+ years equipment maintenance/process experience within a high-volume manufacturing environment (preferably in a Medical Device industry).
- Effective communication skills.
- Self-motivated individual whose willing to learn new engineering disciplines.
- Excellent organisational skills and planning ability.
- Team player.
- Experience in working within a cGMP, regulated environment i.e. ISO certified/FDA.
- Computer literate i.e MS Word, Excel etc.
For more information please contact Christina Keating on 0214944872 or email firstname.lastname@example.org