Quality Engineer

4 weeks ago

Galway, Galway, Ireland Team Horizon Full time

Team Horizon is seeking a Quality Engineerto 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 systemsExcellent attention to detail and significant document review experience essential Excellent technical writing skills including deviation investigation reports and SOPs Skills: GMP C&Q Gamp 5 Regulatory Compliance Documention Benefits: Bonus, Pension, Healthcare

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