LSC seeks a Validation Engineer for a global medical device multinational in the Limerick area for a 12 month contract.
Validation Engineer Role Summary:
o Responsible for supporting 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
o Work with the various departments/groups in development and execution of validation activities associated with new equipment/product or I.M. system upgrades
o Runs /Manages complaint investigation and resolution of same
o Designs and develops validation documentation to support business continuity, new process introductions
o Implementation and co-ordination of the change control process, promotes timely approval of all supporting documentation
o All employees are responsible for minimising both the Environmental and Health & Safety effects of the work that they perform.
Validation Engineer requirements
o Bachelor’s degree from accredited college, Engineering, Information Systems, or an IT qualification
o 3/5 yrs in a Quality function within the Medical Device/ Pharmaceutical industry.
o Have good knowledge of statistical techniques in the use of problem solving/ data analysis.
o Have a proven track record in development/execution of Validation programs in areas of Equipment, Process Information management.
Desirable Requirements for Validation Engineer,
o Be very familiar with the relevant regulatory standards (F.D.A. – Quality System regulations, IS 13485) applicable to the manufacture of Class 111 medical devices to Global markets.
Contact Martin today on 0214777329 for a further discussion or respond directly to this advert with your CV.