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Equipment Project Engineer
22 Feb 2021
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.
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.