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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 manufacturing equipment is a plus.