QC Instrumentation Engineer

This role needs GMP instrumentation depth - not a general QC background.

Our client, a leading biopharmaceutical manufacturer, is hiring a QC Shared Services Instrumentation Senior Specialist to own laboratory instrumentation across its full lifecycle: purchase, installation, qualification, calibration and retirement. This sits within a biopharmaceutical QC environment, reporting to the QC Instrumentation Team Lead.

Key Responsibilities

Delivering calibration and maintenance services across the QC lab, including scheduling and lifecycle tracking

• Leading instrument-specific investigations (e.g. calibration deviations) and trending instrument performance
• Sitting on cross-functional teams with QC, QA Validation and CSV to qualify new instruments
• Acting as the liaison point with sister sites and vendors on instrumentation matters
• Writing and maintaining instrument-related procedures, and troubleshooting complex issues as they come up

Qualification& Experience

A B.Sc. in a scientific discipline, plus at least 3 years' lab experience - including a minimum of 1 year specifically in instrument qualification within a GMP setting

• Direct, hands-on technical experience with biopharmaceutical analytical platforms: HPLC/UPLC, CE, cIEF, SDS-PAGE, Biacore, HIAC, KF, and liquid handlers
• A working understanding of protein biochemistry and the practical needs of drug substance/drug product labs
• Comfort reviewing and approving qualification, calibration and repair documentation - this role signs off on other people's work, not just its own
• The organisational range to run project plans and qualification procedures across multiple instruments and stakeholders at once
• Experience with Data Integrity requirements (21 CFR Part 11 / EU Annex 11)
• Prior involvement in technology transfer projects