Quality Engineer

• This role supports engineering projects and day-to-day operations with a strong focus on compliance, validation, and quality risk management.
• As Quality Engineer, you will act as a key interface between Engineering and Quality functions to ensure all systems and processes meet EU GMP standards and are inspection ready.

• 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.

• Degree in Engineering, Life Sciences, or 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.
• Proven ability to work effectively on their own initiative as well as effectively contributing to the team environment
• Experience working in a matrix role bridging Engineering and Quality departments.
• Knowledge of ISPE Baseline Guides, GAMP 5, and data integrity best practices.
• Six Sigma / Lean certification is advantageous.
• Strong understanding of GMP compliance and quality standards
• Strong Experience of using electronic and physical documentation systems Excellent attention to detail and significant document review experience essential
• Excellent technical writing skills including deviation investigation reports and SOPs

Team Horizon