Validation Engineer


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https://www.teamhorizon.ie/1083-validation-engineer/engineering/galway/job2023-11-09 11:43:451970-01-01Team Horizon
Job TypeContractor
AreaGalway, IrelandGalwayIreland
SectorEngineeringQuality
Start Date
AdvertiserAshling Guthrie
Job Ref3085
Job Views571
Description
Team Horizon is seeking a Validation Engineer for our Clients medical device manufacturing facility in Co. Galway. In this role you will be responsible for the leadership & development of a Validation project team and manageall aspects of equipment & computerized system validation for any software systems used in the manufacture of medical devices.

 

 

Why you should apply:



  • This is an exciting opportunity to join an established mutinational  medical device company, with an opportunity to work on exciting & varied projects


 

 

What you will be doing:



  • Prepare software validation protocols for the Equipment Engineering group.  Execute these protocols and ensure sign-off is obtained at each stage.


  • Creates and executes protocols and reports, reviews Equipment Function Spec's and provides direction and support on validation strategy and plans.


  • Work with Quality department to ensure equipment validations are in line with global &   Site validation standards.


  • Ensure regulatory compliance with  global  software validation requirements.


  • Ensure Computerised system validation procedure(s) is (are) kept up to date and maintained.


  • Take responsibility for correctly carrying out and maintaining all validation and associated documentation for equipment


  • Provides software validation/compliance guidance and training to staff across various functions as required.


  • Develops and enhances cross-functional team relationships and works cross-functionally to identify and resolve technical and organisational issues.


  • Ensure best validation practices are employed by the Equipment Engineering Group so as to maximise effectiveness and minimise non-value added work.Communicates effectively & efficiently with cross-functional teams on project tasks


  • Actively pursues continuous improvement.


  • Complete project deliverables and monitor project schedule and scope changes to assure team can meet delivery requirements for related projects.


  • Generates quotations, concepts and business cases for new and upgarde software systems.


  • Project management of sustaining projects.


  • Manages & mentors contract employees .


 

What you need to apply:



  • Level 8 qualification in Science/Engineering or Quality.


  • Minimum of 5 years’ experience in a Validation role within medical device, biotechnology or pharmaceutical manufacturing organization or equivalent.


  • Proven track record and performance leading validation teams within manufacturing environment. Availability to travel as required.


  • Ability to support weekend work as required.


 

 
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