Laboratory Validation Specialist

2 weeks ago

Dublin, Dublin City, Ireland beBeeQualityControl Full time €55,000 - €85,000
Job Opportunity

We are seeking a highly skilled professional to join our team as a Senior Quality Control Associate.

This is an excellent opportunity for individuals who are passionate about working in a cGMP quality control environment and are looking to develop their skills in laboratory equipment validation and data integrity.

The successful candidate will be responsible for planning, executing, and documenting the qualification, calibration, and routine maintenance of laboratory systems. This will include overseeing tracking and management of activities through CMMS Maximo, authoring and approving validation life cycle documents, and ensuring data integrity compliance.

  • Responsibilities:
  • Plan and conduct routine calibration, requalification, and maintenance of laboratory equipment ensuring calibration and maintenance schedules are adhered to as per CMMS Maximo.
  • Review and file QC calibration and maintenance documentation.
  • Plan, execute, and document the qualification of new laboratory equipment in a cGMP regulated environment.
  • Conduct periodic reviews of instrument validation as part of validation life cycle.
  • Alert quality control management in the event of equipment failing to meet calibration or qualification requirements.
  • Conduct impact assessments/investigations as required.
  • Schedule and coordinate equipment repairs and maintenance with vendors/contractors.
  • Minimize downtime for lab equipment and disruption to laboratory activities.
  • Participate in technical project teams to act as a subject matter expert on instrument validation regulations and procedures.
  • Owning and managing change controls and adherence to Change Control metrics.
  • Supporting and managing the addition of project components to CMMA Maximo.
  • Act as a key contributor and sponsor to Data Integrity Assessments for Lab systems.
  • Any other tasks/projects assigned as per manager's request.
Requirements
  • Bachelor's degree in a Science related field is required.
  • Minimum of 3 years of laboratory experience in a cGMP laboratory environment including exposure to analytical instrument validation and data integrity assessments.
  • Detailed knowledge of the methodology, instrumentation, and analytical techniques used for biopharmaceutical testing.
  • Understanding of current regulatory requirements for cGMP laboratory equipment validation and electronic record integrity.
  • Demonstrated success in managing an equipment qualification or maintenance program is advantageous.

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