Laboratory Equipment Specialist

2 days ago

Dublin, Dublin City, Ireland beBeeLaboratory Full time €65,000 - €85,000

The ideal candidate for this role will have a strong background in laboratory equipment validation and maintenance, with experience working in a cGMP regulated environment.

About the Role

We are seeking an experienced Laboratory Equipment Specialist to join our team. The successful candidate will be responsible for planning, executing, and documenting the qualification, calibration, and routine maintenance of laboratory systems in a cGMP Quality Control environment.

Key Responsibilities
  1. Plan, conduct, and document routine calibration, requalification, and maintenance of laboratory equipment ensuring calibration and maintenance schedules are adhered to as per CMMS Maximo.
  2. Plan, execute, and document the qualification of new laboratory equipment in a cGMP regulated environment, including writing of equipment validation protocols and associated summary reports.
  3. Conduct periodic reviews of instrument validation as part of validation life cycle.
  4. Alert Quality Control Management in the event of equipment failing to meet calibration or qualification requirements and conduct impact assessments/investigations as required.
  5. Schedule and coordinate equipment repairs and maintenance with vendors/contractors, while minimizing level of downtime for lab equipment, and disruption to laboratory activities.
  6. Participate in technical project teams to act as subject matter expert on instrument validation regulations and procedures.
  7. Owns and project manages change controls and adherence to Change Control metrics where applicable.
  8. Support and manage the addition of project components to CMMA Maximo.
  9. Act as key contributor and sponsor to Data Integrity Assessments for Lab systems.
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 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 advantageous.
What We Offer

This is an exciting opportunity to work with a leading organization in the pharmaceutical industry. As a Laboratory Equipment Specialist, you will have the opportunity to develop your skills and expertise in laboratory equipment validation and maintenance.

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