Published 2026-02-24
Validation Lead Engineer, Dun Laoghaire, Dublin
Office/Project Location: Dun Laoghaire, Dublin
Employment Type: Contract
Work Location: Hybrid
Pay: €70 - €100 per hour
Experience: 7+ years
Visa: EU passport or Stamp 4 visa required
Our client is a leading international Biotechnology company with a state of the art aseptic manufacturing facility in Dun Laoighaire, South Dublin.
The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.
This is an excellent opportunity to get experience into Ireland's leading aseptic manufacturing plant.
Validation lead for a large-scale Fill Finish Project in the Pharmaceutical Industry.
Lead a team of Validation engineers to ensure the Validation activities associated with a large fill finish project are completed safely, as per schedule and in compliance with GMP and Quality Requirements.
Coordinates and Supervises all Validation activities
Approves Validation planning documents detailing overall strategy for the project.
Develops and approves the master list of Validation test documents and activities.
Reviews and Approves all C&Q summary reports and Validation Summary reports.
Ensures the Validation schedule is developed and maintained.
Ensures all Validation Engineers who perform Validation activities have relevant training assigned.
Pre-Approval and Post approval of Validation test documents.
Manages Validation coordination meetings.
Responsible for Overall Tracking and Reporting of Validation status and risks/issues.
Assist in the development of User Requirement Specifications (URS’s) and Quality Risk Assessment for Equipment and Automated Systems (QRAES)
Requirements
BS degree with 7+ years of experience in Validation, Engineering, Microbiology or Quality
Extensive knowledge and demonstrated experience managing Validation activities for Pharmaceutical / Biotechnology projects
Experience of sterile / biotech equipment within the pharmaceutical industry is preferred.
Demonstrated strong Communication and Leadership skills.
Demonstrated ability to collaborate with senior stakeholders to achieve optimal outcomes.
Strong understanding of a risk-based approach to commissioning, qualification and validation within the biotechnology industry
In-depth understanding and application of validation principles, concepts, practices, and standards.
In-depth knowledge with c Gx P as well as regulatory regulations and compliance requirements for Biologics Drug Product manufacturing
Working knowledge of sterilization/decontamination systems and industry practices.
Experience with AVS (Airflow Visualization) Studies.
Experience of aseptic processing
Package
Contract role - Hourly rate €70 - €80 per hour
Minimum 12 month contract
Onsite Expectations: 5 days per week.
