I have a fantastic opportunity for a QC Instrumentation Specialist to join the QC Instrumentation team within a leading Biopharmaceutical company in north Dublin. The successful applicant will support the execute of Laboratory Instrumentation Purchase, Installation, Qualification and Lifecycle management. Reporting to the QC Instrumentation Team Lead, 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.
The candidate must have strong experience in all aspects of instrument management in a GMP environment, in addition to an understanding of the needs and best practices of routine biopharmaceutical drug product and drug substance laboratories. They will have responsibility for establishment of project plans and instrument qualification procedures. Experience in Data Integrity management (21 CFR 11/EU Annex 11) is desired.
A strong fundamental understanding of protein biochemistry is desirable, in addition to technical expertise in the following Biopharmaceutical analytical platforms (HPLC/UPLC, CE, cIEF, SDS-PAGE, Biacore, HIAC, KF, Liquid Handlers).
** All candidates must have full right to work in Ireland and currently reside here.
Responsibilities will include;
- 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.
Qualification & Experience:
- Sc. in scientific related discipline
- Must have at least 3 year's industry experience within a biopharmaceutical/pharmaceutical QC lab
- At least 1 year's experience 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.
