Job Description

QC Instrumentation Senior Specialist

Seeking to recruit a QC Instrumentation Senior Specialist to execute Laboratory Instrumentation Purchase, Installation, Qualification and Lifecycle management. The specialist will manage the purchase and qualification of laboratory instruments and will be responsible for providing an Instrument Calibration and Maintenance service to the QC laboratory teams. This is a Dublin based role within a leading Biotech multinational.

Key responsibilities

• Providing a Calibration and/or Maintenance Service to the QC laboratory that includes instrumentation calibrations, scheduling and tracking of instrument maintenance and instrument lifecycle management.

• Review and approve analytical instrumentation qualification, calibration, repairs and documentation.

• Ensure instrument maintenance and verification is appropriate to the use of the instrument

• Manage all instrument specific investigations such as calibration deviations

• Trend lab instrument performance and lifecycle management.

• Participate in new instrument purchase and qualification

• Participate as part of a team of QC Specialists, QA validation Specialists and Computer System Validation personnel to deliver on the qualification of new instruments.

• Liaise with sister sites and vendors on instrumentation purchase, qualification and lifecycle management.

• Ensure compliance with corporate policies, directives and current regulatory requirements for laboratory instrument qualification, calibration and lifecycle management.

• Participate in definition and establishment of instrument related procedures.

• Participate in troubleshooting complex instrumentation issues.

Education and Qualifications:

The ideal candidate should hold a minimum of a B.Sc. in scientific related discipline and must have at least 3 year’s experience within the pharma/biotech industry, at least 1 of which should be related to instrument qualification experience in a GMP laboratory setting. Previous experience in technology transfers would be advantageous.

The successful candidate must demonstrate the ability to contribute to and lead in a team based collaborative environment, as well as the ability to prioritise objectives from multiple projects. The successful candidate must demonstrate time management and organisational skills and excellent communication is essential