Job Description
We are seeking a highly skilled Quality Engineer to join our engineering team at a biopharmaceutical facility in Ireland.
The successful candidate will support engineering projects and day-to-day operations with a strong focus on compliance, validation, and quality risk management.
Key Responsibilities:
* Evaluate and ensure that all engineering activities are carried out in compliance with 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.
* Support preparation for regulatory inspections and internal audits relating to engineering systems and GMP compliance.
* Maintain and improve engineering quality processes.
Requirements
* Degree in Engineering, Life Sciences, or a related technical discipline.
* 5+ years' experience in a pharmaceutical, biopharma, or medical device environment.
* Strong knowledge of validation principles and engineering best practices.
* Hands-on experience with C&Q documentation, risk-based validation, and change management processes.