Validation Engineer
Our client is a regulated pharmaceutical manufacturing organisation with a strong focus on quality, compliance, and continuous improvement.
This role sits within the Quality Assurance function and reports directly to the Head of Quality.
The Validation Engineer will play a key role in managing and coordinating validation activities across the site and with external partners.
Location: East Galway
Employment Type: Permanent
Responsibilities
Support the preparation, review, and maintenance of the Validation Master Plan (Process and Cleaning).
Manage validation activities across internal operations, third‑party suppliers, and CMOs.
Prepare, review, and approve validation protocols and reports for equipment, cleaning, process, and computer systems.
Own and maintain the site cleaning validation strategy in line with EU regulatory requirements.
Lead process validation activities for new products supporting regulatory submissions.
Coordinate execution of validation activities with Production, Quality Control, and R&D teams.
Manage change controls and non‑conformances with validation impact.
Maintain validation documentation and ensure timely close‑out of protocols.
Support internal, regulatory, and customer audits.
Provide technical input and lead cross‑functional teams to resolve validation‑related issues.
Requirements
Bachelor's degree in Science, Engineering, or a related discipline.
Minimum 2 years' experience in a validation role within a GMP‑regulated environment.
Strong knowledge of process and cleaning validation.
Experience working to HPRA and/or FDA requirements.
Strong communication skills and ability to work cross‑functionally.
Well‑organised, proactive, and detail‑oriented.
Contact Gerard Cunniffe at +353861908885.
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