Quality Engineer

Team Horizon is seeking a Quality Engineer to join our clients Engineering team at a GMP-regulated biopharmaceutical facility in Ireland. This role supports 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.

Why you should apply:

• 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.

What you will be doing:

• 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.

What you need to apply:

• 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