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Validation Quality Engineer

Our Client a Global Medical Device Company based here in Galway is seeking a Validation Quality Engineer.


As part of this role, you will gain knowledge and experience in Cleanroom design, building design, energy systems (BSC Galway is ISO 50001 certified), purified water systems, compressed air system, Liquid Nitrogen and Argon systems, AHU’s and MAHU’s, BMS (Building Management System), CMS (Critical Management System), boilers, CHP, Heat Pumps, Chilled Water Systems, Steam systems, humidifiers.

 

Key Responsibilities:


  •  Responsible for the qualification cleanrooms and critical building services such as purified water, compressed air, bulk gas systems (e.g. Nitrogen, Argon), CMS (Critical Management System), etc.
  • Support the maintenance requirements of Facilities systems so that they meet specifications and standards.
  •  Responsible for supervision of Facility project work and ensuring that the work is implemented as per standards and that the program is completed on schedule, within budget.
  •  Ensure that all maintenance routines, procedures and drawings are current and that proper handover of these occur at the end of the project. 
  • Responsible for maintaining and updating Facilities procedures.
  • Supporting the Environmental Management Programme.

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Requirements:


  •  Level 8 Degree in Mechanical Engineering.  
  • 1-2 years’ experience in an engineering position.
  •  Must have QS experience.
  •  Influential team member, fully motivated to achieve and demonstrate best practices in line with the department and site objectives.
  •  Familiarity with FDA, ISO9000 and ISO14000 Standards a plus.
  •  Must be flexible, capable of working in a demanding/challenging environment, professional attitude, and good communication skills. Good computer skills are essential.
  •  Certified Facilities Management (CFM) and/or project management (PMP) is an advantage.
  •  Experience working with outside vendors and subcontractors.
  •  Introduction of systems through effective organisational change management.
  •  Must have a proven track record in continuous improvement and problem solving.
  •  Is a good communicator and has strong stakeholder management skills.  
  •  Exceptional customer service, relationship building and communication skills.
  •  Confident in writing reports.

For a confidential discussion and more information about the role please contact Michelle Mc Inerney

091 706 717

Michelle.mcinerney@collinsmnicholas.ie