Job Summary:
The Senior Specialist is responsible for executing 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. Knowledge 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. Responsible for establishment of project plans and instrument qualification procedures.
Main responsibilities include:
1. Providing a Calibration and Maintenance Service to the QC laboratory that includes instrumentation calibrations, scheduling and tracking of instrument maintenance and instrument lifecycle management.
2. Review and approve analytical instrumentation qualification, calibration, repairs and documentation.
3. Ensure instrument maintenance and verification is appropriate to the use of the instrument
4. Manage all instrument specific investigations such as calibration deviations
5. Trend lab instrument performance and lifecycle management.
6. Participate in new instrument purchase and qualification
7. 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.
8. Liaise with sister sites and vendors on instrumentation purchase, qualification and lifecycle management.
9. Ensure compliance with corporate policies, directives and current regulatory requirements for laboratory instrument qualification, calibration and lifecycle management.
10. Participate in definition and establishment of instrument related procedures.
11. Participate in troubleshooting complex instrumentation issues.
Key Requirements:
12. Minimum of a B.Sc. in scientific related discipline and must have at least 3 year's experience, at least 1 of which should be related to instrument qualification experience in a GMP laboratory setting.
13. Previous experience in technology transfers would be advantageous.
14. 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).
15. Experience in Data Integrity management (21 CFR 11/EU Annex 11) is desired.
16. Demonstrative ability to contribute to and lead in a team based collaborative environment, as well as the ability to prioritize objectives from multiple projects.
17. Must demonstrate time management and organizational skills and excellent communication is essential.
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