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QC Instrumentation Specialist

3 weeks ago

Limerick, Limerick, Ireland Life Science Recruitment Full time

Life Science Recruitment

About the Role

A career-defining opportunity has arisen for a highly skilled QC Instrumentation Specialist to join our esteemed client's greenfield biotech manufacturing site in Limerick. This is a fully site-based permanent position, offering a unique chance to contribute to the success of a pioneering project.

Key Responsibilities
  • Equipment Qualification and Validation: Author, execute, and review equipment qualification/validation protocols and strategies for the QC Laboratories, ensuring seamless integration with existing systems.
  • Laboratory Informatics and Connectivity: Support equipment lifecycle management and laboratory informatics initiatives, integrating QC instrumentation with LIMS and e-Systems to achieve a paper-less laboratory environment.
  • Maintenance Coordination: Act as liaison between the maintenance team and lab personnel to schedule preventative and corrective maintenance of equipment, guaranteeing optimal performance and compliance.
  • Data Integrity and Compliance: Responsible for coordination of laboratory CSV activities, system upgrades, and data integrity, maintaining the highest standards of GMP compliance.
Requirements

To succeed in this role, you will need:

  • 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
  • Working knowledge of CMMS, Kneat, Empower, TrackWise, LabVantage LIMS, Veeva
  • Understanding of compliance requirements and regulatory expectations for GMP systems