Reporting to: Engineering and Facilities Manager
Location: Dublin 15
Employment Type: Full Time
Industry: Logistics and Supply Chain - Pharmaceuticals
About the Role
We are recruiting an experienced and motivated Validation Specialist to join our team. This is an excellent opportunity for professionals with a strong validation background who are looking to develop their career further. The role works cross functionally and plays a key part in developing and strengthening the company validation processes.
*The ideal candidate will have validation experience in warehousing and transport, not lab-based backgrounds.*
Key Role Responsibilities
Generate and execute validation protocols, review project change controls, and prepare all required documentation and reports.
Generate, execute, and close out validation projects for existing products and new product introductions.
Execute and document validation related risk assessments.
Assess validation requirements for new equipment, systems, and change controls, monitor project progress, and provide timely updates.
Maintain validation status through monthly reports and meetings, working closely with project managers to meet schedules.
Investigate, track, and resolve deviations that occur during qualification activities.
Participate in project teams and support the development of project schedules and appropriate validation levels.
Proactively support the direct Supervisor to achieve departmental and site objectives and complete assigned projects.
Build and maintain positive cross functional relationships.
Ensure GxP compliance and stay informed on validation best practices and innovation.
Contribute to the development of company validation standards and support department growth when required.
Present professionally to management and auditors, support internal processes, and respond to queries during regulatory inspections.
Liaise with relevant QA personnel to ensure project documentation is completed within defined timeframes.
About You
Bachelor’s degree in Science, Engineering, Technology, or a related discipline.
Minimum of 3 years hands-on experience working as a Validation Engineer or Specialist in a GxP environment.
Experience in a similar validation focused role, particularly involving warehouses, transportation, and CTUs.
Knowledge of HVAC and refrigeration systems, including automation.
Excellent communication skills with the ability to explain technical information to non subject matter experts.
Ability to quickly gather, understand, analyse, and interpret information and technical concepts.
Experience in end to end qualification, including URS development and IQ, OQ, and PQ execution.
For further information, contact alan on alan(at)accpro(dot)ie
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