A QC Instrumentation Engineer is required for a greenfield biotech manufacturing site in Limerick. This is a fully site-based permanent position.
The key focus of this role is to provide equipment lifecycle management support to the QC Laboratories.
Main Responsibilities:
* Author, execute, and review equipment qualification/validation protocols and strategies for the QC Laboratories.
* Support equipment lifecycle management and laboratory informatics initiatives.
* Support equipment connectivity activities, integrating QC instrumentation with Laboratory Information Management Systems (LIMS) and enterprise systems to achieve a paperless laboratory.
* Act as liaison between the maintenance team and lab personnel to schedule preventative and corrective maintenance of equipment.
* Coordinate laboratory change control activities, system upgrades, and data integrity.
Requirements:
* Bachelor's degree (Hons) in an engineering-related field (Mechanical Engineering, Biomedical Engineering, etc.).
* At least 2 years of experience with equipment, with emphasis on Good Manufacturing Practice (GMP) instrumentation.
* Experience supporting analytical equipment in a GMP environment.
* Working knowledge of Computerized Maintenance Management Systems (CMMS), Kneat, Empower, TrackWise, LabVantage LIMS, Veeva.
* Understanding of compliance requirements and regulatory expectations for GMP systems.