Senior QC Instrumentation Specialist - GMP Calibration

Bristol-Myers Squibb Co; Dublin; Vor Ort; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

Bristol Myers Squibb in Ireland seeks a QC Shared Services Instrumentation Senior Specialist to manage calibration, maintenance and lifecycle management of QC instruments in a GMP environment.

You will review instrument qualification and calibration documentation, liaise with vendors, and support instrument-related procedures while ensuring regulatory compliance and cross-site cooperation.

Qualifikationen

• B.Sc. in scientific discipline required; min 3 years’ experience in instrument qualification in GMP lab.
• Experience with Data Integrity (21 CFR 11/EU Annex 11) desired.
• Strong GMP instrument management, calibration and lifecycle management experience.
• Experience in technology transfers would be advantageous.

Aufgaben

• Provide calibration and/or maintenance service to QC lab including calibrations, maintenance scheduling, lifecycle management.
• Review and approve instrument qualification, calibration, repairs and documentation.
• Ensure instrument maintenance and verification is appropriate to instrument use.
• Manage instrument-specific investigations such as calibration deviations.
• Trend lab instrument performance and lifecycle management.
• Participate in new instrument purchase and qualification.
• Collaborate with QC Specialists, QA validation Specialists and CSV personnel to qualify new instruments.
• Liaise with sister sites and vendors on instrument lifecycle management.
• Ensure compliance with corporate policies and regulatory requirements for instrument qualification, calibration and lifecycle management.
• Participate in establishing instrument-related procedures.
• Troubleshoot complex instrumentation issues.

Kenntnisse

GMP experience

Instrument management

Data Integrity

Biopharmaceutical analysis

Ausbildung

B.Sc. in scientific discipline

Tools

HPLC/UPLC

CE

cIEF

SDS-PAGE

Biacore

HIAC

KF

Jobbeschreibung

Bristol Myers Squibb in Ireland seeks a QC Shared Services Instrumentation Senior Specialist to manage calibration, maintenance and lifecycle management of QC instruments in a GMP environment.

You will review instrument qualification and calibration documentation, liaise with vendors, and support instrument-related procedures while ensuring regulatory compliance and cross-site cooperation.