QC Instrumentation Lead — Calibration & Lifecycle (GMP)

Bristol Myers Squibb UK & Ireland; Ireland; Vor Ort; EUR 65.000 - 90.000; Vollzeit

Zusammenfassung

Bristol Myers Squibb UK & Ireland is seeking a QC Shared Services Instrumentation Senior Specialist to manage calibration, maintenance and qualification of laboratory instruments in a GMP QC setting. You will coordinate instrument lifecycle management and support QC teams with qualification documentation and investigations.

The ideal candidate will hold a minimum B.Sc in a scientific discipline with at least 3 years of instrument qualification experience, and exposure to Data Integrity practices

Qualifikationen

• Minimum of a B.Sc in a scientific discipline.
• At least 3 years' experience with instrument qualification in a GMP laboratory setting.
• Experience in Data Integrity management (21 CFR 11/EU Annex 11) is desirable.
• Desirable: strong understanding of protein biochemistry.

Aufgaben

• Provide Calibration and/or Maintenance service to the QC laboratory, including instrument calibrations and lifecycle management.
• Review and approve instrument qualification, calibration, repairs and documentation.
• Ensure instrument maintenance/verification aligns with 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/QA/CSV teams to qualify new instruments.
• Liaise with sister sites and vendors on instrument lifecycle management.
• Ensure compliance with corporate policies and regulatory requirements.

Kenntnisse

GMP experience

Data Integrity

Instrument qualification

Team collaboration

Biopharma analytics

Ausbildung

B.Sc in scientific discipline

Tools

HPLC/UPLC

CE

cIEF

SDS-PAGE

Biacore

HIAC

KF

Liquid Handlers

Jobbeschreibung

Bristol Myers Squibb UK & Ireland is seeking a QC Shared Services Instrumentation Senior Specialist to manage calibration, maintenance and qualification of laboratory instruments in a GMP QC setting. You will coordinate instrument lifecycle management and support QC teams with qualification documentation and investigations.

The ideal candidate will hold a minimum B.Sc in a scientific discipline with at least 3 years of instrument qualification experience, and exposure to Data Integrity practices