Now Hiring: QC Instrumentation Senior Specialist – Biologics
Contract Duration: 12 Months
Location: Dublin, IE
We're looking for a QC Shared Services Instrumentation Senior Specialist to join a growing biologics team and support cutting-edge laboratory operations. This is an exciting opportunity for someone with strong experience in laboratory instrumentation management within a GMP biopharmaceutical environment.
In this role, you will be responsible for the procurement, qualification, calibration, and lifecycle management of analytical instruments across QC labs. You'll work closely with cross-functional teams to ensure instrumentation is compliant, maintained, and optimized for performance.
Key Responsibilities:
* Deliver a Calibration and Maintenance Service for QC laboratories, including scheduling, tracking, and managing instrumentation lifecycles.
* Review and approve qualification protocols, calibration records, repair documentation, and associated reports.
* Lead investigations related to instrumentation performance and calibration deviations.
* Participate in the selection, purchase, qualification, and troubleshooting of new laboratory instruments.
* Collaborate with QC, QA Validation, and Computer Systems Validation teams to ensure compliant instrument integration.
* Develop and maintain procedures related to instrument qualification and lifecycle management.
* Interface with vendors and other global sites on instrumentation strategy and support.
* Ensure full compliance with internal policies and external regulatory requirements (21 CFR Part 11 / EU Annex 11).
Qualifications & Experience:
* B.Sc. in a scientific discipline required.
* Minimum of 3 years' experience in a GMP laboratory setting, with at least 1 year focused on instrument qualification.
* Experience in Data Integrity practices and regulatory expectations is highly desirable.
* Solid understanding of biopharmaceutical analytical techniques, such as:
* HPLC/UPLC
* Capillary Electrophoresis (CE)
* cIEF
* SDS-PAGE
* Biacore
* HIAC
* Karl Fischer (KF)
* Liquid Handling Systems
* Familiarity with technology transfer processes is an advantage.
What We're Looking For:
* Strong technical knowledge and troubleshooting skills.
* Experience managing multiple priorities and cross-functional projects.
* Excellent communication and collaboration in a team-based environment.
* Detail-oriented with strong organizational and time-management abilities.
This is a fantastic opportunity for a motivated and experienced professional looking to advance their career in a collaborative and innovative biologics environment.
Apply now or reach out to learn more.