Quality Engineer

20 hours ago

Sligo, Sligo, Ireland Cpl Healthcare Full time

JO-
Our client - a GMP-regulated biopharmaceutical facility in Sligo, requires a Quality Engineering to join their engineering team.
The successful candidate will support engineering projects and day-to-day operations with a strong focus on compliance, validation, and quality risk management.
The Quality Engineer acts as a key interface between Engineering and Quality functions to ensure all systems and processes meet EU GMP standards and are inspection ready.
Please note - applicants need to have a stamp 4 or to have unrestricted full working rights for Ireland
Responsibilities:

•Ensure engineering activities are carried out in compliance with GMP and site quality standards.

•Provide oversight for equipment qualification, utility validation, facility modifications, and engineering change controls.

•Support the commissioning and qualification (C&Q) lifecycle, including document review and approval of protocols (IQ/OQ/PQ), risk assessments, and summary reports.

•Lead or support investigations related to engineering deviations, non-conformances, and CAPAs ensuring timely closure and root cause identification.

•Participate in cross-functional project teams for new equipment introduction, process improvements, and site upgrades, ensuring quality is embedded throughout.

•Act as quality representative within engineering-led initiatives (e.g., reliability improvements, energy efficiency upgrades).

•Support preparation for regulatory inspections (e.g. HPRA) and internal audits relating to engineering systems and GMP compliance.

•Maintain and improve engineering quality processes, such as document control, calibration systems, and preventative maintenance compliance.

•Undertake other tasks as assigned by the engineering manager.
Requirements

•Degree in Engineering, Life Sciences, or a related technical discipline.

•5+ years' experience in a GMP-regulated pharmaceutical, biopharma, or medical device environment.

•Strong knowledge of validation principles, engineering best practices, and regulatory requirements under GMP.

•Hands-on experience with C&Q documentation, risk-based validation, and change management processes.

•Familiarity with engineering systems such as CMMS (eMaint), BMS (IQ vision), and automated manufac turing equipment is a plus.
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