QC Instrumentation Engineer

Next Generation; Dublin; On-site; EUR 55,000 - 75,000; Full time

Job summary

Next Generation is seeking a skilled QC Instrumentation Specialist to ensure instruments remain fit for use and compliant with GMP requirements in drug substance and drug product testing. You will coordinate calibration, maintenance and lifecycle activities while reviewing and approving qualification documentation.

You will support instrument purchasing and qualification with QC, QA Validation and CSV teams, investigate deviations, and develop compliant procedures across platforms such as

Qualifications

• GMP instrumentation depth is required.
• BSc in a relevant scientific discipline is required.
• Minimum three years’ experience, including at least one year in instrument qualification within a GMP laboratory.
• Strong experience in instrument management, calibration and maintenance.
• Understanding of regulatory data integrity requirements (21 CFR Part 11, EU Annex 11).

Responsibilities

• Coordinate instrument calibration, maintenance and lifecycle activities.
• Review and approve instrument qualification, calibration, repair and maintenance documentation.
• Establish qualification procedures and project plans for new laboratory instruments.
• Support instrument purchasing, installation and qualification with QC, QA Validation and CSV teams.
• Investigate instrument issues and calibration deviations and troubleshoot faults.
• Ensure maintenance and verification activities suit each instrument’s use.
• Liaise with vendors and sites on instrument purchasing, qualification and support.
• Develop instrument procedures and maintain regulatory compliance.

Skills

GMP instrumentation depth

instrument management

calibration

data integrity

communication

time management

leadership

Education

BSc in a relevant scientific discipline

Tools

HPLC/UPLC

CE

cIEF

SDS-PAGE

Biacore

HIAC

Karl Fischer

liquid handlers

Job description

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

Reporting to the QC Instrumentation Team Lead, you will ensure laboratory instruments remain fit for use and compliant with GMP requirements, supporting drug substance and drug product testing.

Key Responsibilities

• Coordinate instrument calibration, maintenance and lifecycle activities, including scheduling and tracking.
• Review and approve instrument qualification, calibration, repair and maintenance documentation.
• Establish qualification procedures and project plans for new laboratory instruments.
• Support instrument purchasing, installation and qualification alongside QC, QA Validation and Computer System Validation teams.
• Investigate instrument issues and calibration deviations, troubleshoot faults and trend instrument performance.
• Ensure maintenance and verification activities are appropriate for each instrument’s intended use.
• Liaise with vendors and other sites on instrument purchasing, qualification and ongoing support.
• Develop instrument procedures and maintain compliance with corporate policies and regulatory requirements.
• BSc in a relevant scientific discipline.
• Minimum three years’ relevant experience, including at least one year in instrument qualification within a GMP laboratory.
• Strong experience in laboratory instrument management, calibration and maintenance.
• Understanding of routine biopharmaceutical QC laboratory requirements and practices.
• Strong organisational, communication and time management skills, with the ability to prioritise multiple projects.
• Ability to work collaboratively and lead assigned activities.
• Knowledge of data integrity requirements, including 21 CFR Part 11 and EU Annex 11.
• Technical experience with platforms such as HPLC/UPLC, CE, cIEF, SDS-PAGE, Biacore, HIAC, Karl Fischer and liquid handlers.
• Understanding of protein biochemistry.
• Previous involvement in technology transfers.