Validation Engineer - Contractor

https://www.teamhorizon.ie/job-search/1702-validation-engineer-contractor/engineering/mayo/job2025-12-02 09:36:372053-04-17Team Horizon
Job TypeContractor
AreaMayo, IrelandRoscommon, IrelandSligo, IrelandLeitrim, IrelandDonegal, IrelandMayoIreland
SectorEngineeringQuality
Start Date
AdvertiserAshling Guthrie
Job Ref3785
Job Views658
Description

Team Horizon is seeking a Validation Engineer for our Clients manufacturing facility in Connaught on a 6-month initial contract. You will coordinate, implement, and actively contribute to the site’s Validation Program—ensuring full compliance with regulatory, data integrity, and company requirements.


 


 


Why you should apply:



  • This is a high-impact role with autonomy and visibility across multiple functions.


 


What you will be doing:



  • Ensure all Computerized systems are qualified in compliance with Data Integrity policies
    and regulatory requirements.

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

  • Generation/maintenance of the Validation Master Plans.

  • Generation/maintenance of Project Validation Plans.

  • Generation of validation plans, protocols and final reports to cGMP standard.

  • Understanding of Risk based equipment qualification, Equipment Risk Assessments, Critical Elements Test Plan development

  • Review / approval of all protocols and final reports.

  • Management of validation change control process.

  • Adheres to and supports all EHS & E standards, procedures and policies


 


What you need to apply:



  • A minimum of 5-10 years’ experience in a cGMP regulated environment.

  • A good understanding of regulatory requirements.

  • Must have hands on experience of execution of IQ/OQ/PQ for Facilities/ Utilities/ Equipment in Pharmaceuticals or Medical Devices or Diagnostics 

  • Requires a high level of attention to detail and mental concentration, to ensure accuracy and total compliance with procedures at all times.

  • Requires proven problem-solving skills and the ability to adapt to new regulatory requirements.

  • Requires innovative thinking, where new and untested solutions are proposed, demonstrated and implemented on a regular basis.

  • Must be results driven striving to meet all targets and metric standards as set by site/department and division leaders.

  • Requires total commitment to quality and maintaining a high standard of work at all times.

  • Demonstrates the highest levels of integrity and a strong work ethic at all times

  • Strong communication skills both verbal and written are required for the execution of this role.


 


 

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