QC Instrumentation Lead — GMP Calibration & Lifecycle

Bristol Myers Squibb; Ireland; On-site; EUR 70,000 - 90,000; Full time

Job summary

Bristol Myers Squibb is recruiting a QC Shared Services Instrumentation Senior Specialist to manage calibration, maintenance, and lifecycle management of laboratory instruments in a GMP QC setting.

The role involves reviewing instrumentation qualifications, coordinating maintenance, and leading instrument-related investigations. Strong collaboration with QC teams and external vendors is essential for successful qualification and regulatory compliance.

Qualifications

• Minimum of a B.Sc in scientific related discipline and at least 3 years’ experience, at least 1 of which relates to instrument qualification in a GMP lab.
• Experience in Data Integrity (21 CFR 11/EU Annex 11) is desirable.
• Previous experience in technology transfers would be advantageous.

Responsibilities

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

Skills

Instrument qualification

GMP environment

Calibration

Maintenance

Data integrity

Education

B.Sc. in scientific related discipline

Tools

HPLC/UPLC

CE

cIEF

SDS-PAGE

Biacore

HIAC

KF

Liquid Handlers

Job description

Bristol Myers Squibb is recruiting a QC Shared Services Instrumentation Senior Specialist to manage calibration, maintenance, and lifecycle management of laboratory instruments in a GMP QC setting.

The role involves reviewing instrumentation qualifications, coordinating maintenance, and leading instrument-related investigations. Strong collaboration with QC teams and external vendors is essential for successful qualification and regulatory compliance.