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Equipment Project Engineer

Ref: 9222572

  • €0/Hour
  • 22 Feb 2021
  • Cork (Centre)
  • Temp Regular

One of my favourite clients in Cork has just opened some really interesting 2 year contract roles in Equipment and Project Engineering. Driven by expansion they need a number of committed and ambitious Engineers to help them role out advances in their manufacturing lines and processes. If you have 5+ years in a Medical Device environment and experience of either the introduction of new Automated Manufacturing Lines or alternatively Product/Process Validations then give me a call on 087 3618142 or message me here for more. In this role you will contribute throughout the Automated Equipment Life Cycle - through development phase / specification phase / design phase / construction phase & qualification phase. You will work closely with selected vendors on the design, build, debug and installation of specified pieces of equipment, including significant contribution to the URS, FAT, SAT, IQOQ & OQPQ in collaboration with the validation engineer, process engineer and project technician.

About the Job:

  • Participate in a cross functional project team to establish to support the development and introduction of the new automated production equipment
  • Contribute to the specification of the equipment. Work in conjunction with the Process Engineer to develop appropriate URS documents for each larger element of the line.
  • Support the validation engineer in the development of the Functional Specifications, Trace Matrix.
  • Drive design reviews and build inspections with Equipment vendors.
  • Drive regular status review meetings with vendors.
  • Develop and maintain project timeline for various pieces of equipment.
  • Set-up vendor FAT and support the validation engineer in preparing and executing FAT / SAT protocols.
  • There will be a requirement to travel to Equipment Manufacturer in Europe for short trips as part of this project (for design reviews/ build inspections / FAT execution).
  • Lead the installation phase of the equipment.
  • Support the validation engineer in preparing and executing Equipment IQ & OQ Protocols and the preparation of associated reports.
  • Work in conjunction with the Process/Manufacturing Engineer to prepare for and execute Process OQ/PQ protocols.
  • Any other responsibility as set out by Supervisor/ Manager.
  • About you:

  • A qualification in appropriate Engineering discipline and at least 6 years relevant experience in a regulated environment.
  • Previous Experience in the development / validation / & commissioning of automated manufacturing equipment is essential.
  • Working knowledge of PLCs and assembly automation control systems a distinct advantage.
  • Working knowledge of vision systems an advantage.
  • Working knowledge of moulding equipment an advantage.
  • Strong vendor management experience required.
  • Good regulatory knowledge.
  • Good verbal and written communication skills, including the ability to conduct verbal presentations.
  • Demonstrated success working in a team environment.
  • Ability to work under pressure to meet scheduled deadlines.
  • Proven technical protocol and report writing skills.
  • For more on the role call Nigel on 087 3618142 or send your CV for consideration.