A QC Instrumentation Engineer is required to join 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 support functions include specifying and purchasing equipment; authoring equipment qualification packages, managing the equipment qualification process, and providing daily operational support of laboratory equipment by ensuring the equipment is maintained in a qualified state of compliance.
Key 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 LIMS and e-Systems to achieve a paper-less laboratory.
* Act as liaison between the maintenance team and lab personnel to schedule preventative and corrective maintenance of equipment.
* Responsible for coordination of laboratory CSV activities, system upgrades, and data integrity.
Basic Requirements:
* Bachelor’s degree (Hons) in an engineering related field (Mechanical Engineering, Biomedical Engineering, etc.)
* 2 or more years of equipment experience with emphasis on GMP instrumentation.
* Experience supporting analytical equipment in a GMP environment.
* The ideal candidate will have working knowledge of CMMS, Kneat, Empower, TrackWise, LabVantage LIMS, Veeva.
* Understanding of compliance requirements and regulatory expectations for GMP systems.
For further details please contact Paula O’Reilly on 087 7094141 or send CV in confidence to paula.oreilly@lifescience.ie.
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