Contract
QC Instrumentation Engineer
Posted on 07 September 26 by Chantel Maluleka
- Dublin
- €30.80 - €30.80 per Hour
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Job Description
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
Strong pluses (not dealbreakers):
- Experience with Data Integrity requirements (21 CFR Part 11 / EU Annex 11)
- Prior involvement in technology transfer projects
If your CV doesn't show GMP instrument qualification experience, this specific role isn't the right fit — but we'd still encourage you to get in touch about other QC opportunities at Next Generation.
Apply with your CV to enquiries@nextgeneration.ie