Validation Engineer

Team Horizon is seeking a Validation Engineer for a 12-month contract for our client’s manufacturing facility in Sligo.

Why you should apply:

• Exciting opportunity to join a global pharmaceutical company and join a dierse and experienced team

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.


• 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:

• 3rd level qualification in a relevant engineering or scientific discipline.


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


• A good understanding of regulatory requirements.


• Experience in Process validation (PPQ) in API or Drug product and experience with managing validation events / Non-Conformances during PPQ


• FUE qualification essential (preferably API). Experience with working in fast paced projects. Understanding of ASTM E2500 risk-based qualification.


• Good understanding of Critical Process Parameters/ Non critical process parameters and their relationship with instrument calibration tolerances and selection of PPQ test criteria


• Ability to work directly with Engineering and other stakeholders to understand validation requirements.


• Ability to react to problems quickly during validation.