Validation Engineer


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https://www.teamhorizon.ie/1264/job2024-04-17 16:22:081970-01-01Team Horizon
Job TypePermanent
AreaSligo, IrelandSligoIreland
SectorEngineeringQuality
Start Date
AdvertiserAshling Guthrie
Job Ref#3268
Job Views506
Description

Team Horizon is seeking a Validation Engineer on a permanent basis for our client’s manufacturing facility in the North West.


 


 


Why you should apply:



  • You will get the opportunity to coordinate, implement and actively participate in the site Validation Program and general Technical Operations activities


 


What you will be doing:



  • Coordination / direction and active participation in the validation of site Facility, equipment, utilities, processes and software in compliance with company policies, FDA, European cGMP and GAMP standards.

  • Generation/maintenance/execution of the Site Validation Master Plan, Project Validation Plans and schedules

  • Generation of validation protocols and final reports to cGMP standards.

  • Generation of validation investigations and implementation of corrective actions.

  • Creation, review and approval of various quality documents and test data.

  • Management of validation exception events and change control processes.

  • Maintenance and tracking of validation equipment, if applicable.

  • Performing cross training within the team and training of new team members.

  • Participation in continuous improvement programs to implement improvements in manufacturing, quality, safety and training systems.

  • Communicating with peers and management regarding activities in the area, including elevation of events or concerns.


 


What you need to apply:



  • Qualification and/or degree in engineering or scientific discipline. 

  • 3 years plus validation experience in pharmaceutical, diagnostics or medical device industry  

  • 3 years plus of knowledge of cGMP and regulatory requirements relating to pharmaceutical, diagnostics or medical device industry.  

  • Strong communication (written and oral), presentation and troubleshooting skills required.  

  • Effective interpersonal and organizational skills


 


 

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