Validation Engineer


Job Detail

Location Galway
Salary Negotiable
Role Type Permanent
Contact Aisling Kidney

Validation Engineer

Apply Now

Job ID: JOB-13052
Validation Engineer


An important role in the QA department, reporting directly to the QA Compliance/Qualified Person, the Validation Engineer will be responsible for reviewing and issuing of validation protocols and reports and also the co-ordination of the execution of validation activities (process / cleaning and equipment and computer qualifications) with the relevant departments.


  • Contribute on the preparation and review of the Validation Master Plan – Process and Cleaning.
  • Manage the validation requirements of third party suppliers and CMO’s.
  • Manage the preparation, review and issuing of Validation Protocols and Reports (this to include equipment, cleaning, process and computer system validation).
  • To maintain and take responsibility for the cleaning validation strategy
  • To assume responsibility for the cleaning validation master plan confirming to accepted practices and demands of the competent authorities in the EU.
  • Implementation of Process Validation of new products for regulatory submissions ensuring compliance to proposed registered specifications.
  • Coordination of the execution of Validation in accordance with protocols by Production, Quality Control and R&D teams.
  • Establishing, implementing and directing validation and revalidation activities.
  • Liaise with contract manufacture customers in seeking their approval for protocols and reports where appropriate.
  • Reviewing and managing Change Control Forms for Validation implications.
  • Reviewing and managing Non-Conformance’s for Validation Implications.
  • Updating existing quality documentation related to validation activities.
  • Identifying training requirements in support of validation.
  • Ensuring completion of validation protocols.
  • Carry out Internal Audits as required.
  • Responsible for the execution of Risk Assessments or Investigation reports relative to the role.
  • Maintaining validation documentation system.
  • Required to Lead cross functional teams providing knowledge in resolution in any technical issues.
  • Assisting in the preparation and hosting of associated regulatory and customer audits.


  • Minimum Bachelor of Science or Engineering.
  • 4-5 years’ experience in a pharmaceutical environment.
  • Good computer skills with Word, Excel and any other statistical programs.
  • Knowledge of Process and Cleaning Validation.
  • Ability to conduct internal audits.
  • Ability to perform in external audits

For further information on this role in Galway please contact Aisling Kidney on 0872197421 or

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Aisling Kidney


Apply Now

Validation Engineer

Aisling Kidney

Role Type Permanent
Contact Aisling Kidney
mobile +353 0872197421
linkedIn profile click here

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