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Senior Validation Engineer

Reference ID : 410MQ
Category :
  • Medical Devices
Date Posted : Jun 28, 2019
Job Location
  • Munster
- Limerick
Experience : 3-5 years in a Quality function within the Medical Device/ Pharmaceutical industry.
Salary : Negotiable - DOE
Employment Type
Michael McQuade
Contact Number : 086-0435195
Headcount Engineering is seeking a Senior Validation Engineer to join our team at a client’s medical device facility in Limerick.

Principal Responsibilities

The Validation engineer will support the activities of Operations / Engineering / Information Management in assuring compliance with the pertinent regulations and will work with all departments in ensuring operational effectiveness and developing product Quality for business continuity and process/product introductions. 

  • Develop Validation Documentation to support new process/product introductions and existing business continuity and process improvement requirements.
  • Support the activities of Operations / Engineering / Information Management in building Product Quality into our products and assuring compliance to the pertinent regulations while at the same time attaining operational effectiveness 
  • Work with the various departments/groups in development and execution of validation activities associated with new equipment/product or I.M. system upgrades 
  • Run /Manage complaint investigation and resolution of same 
  • Design and develop validation documentation to support business continuity, new process introductions 
  • Implementation and co-ordination of the change control process, promotes timely approval of all supporting documentation 

Qualifications & Requirements

  • Bachelor’s degree in relative engineering discipline. 
  • 3-5 years in a Quality function within the Medical Device/ Pharmaceutical industry. 
  • Good knowledge of statistical techniques in the use of problem solving/ data analysis. 
  • Proven track record in development/execution of Validation programs in areas of Equipment, Process Information management 
  • It is desirable to be very familiar with the relevant regulatory standards (F.D.A. - Quality System regulations, ISO-13485) applicable to the manufacture of Class III medical devices to Global markets.


For further information, please contact Mick on 086-0435195 or forward details in confidence to jobs@headcount.ie

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