Senior Quality Engineer

1 day ago

Sligo, Sligo, Ireland beBeeEngineering Full time
Job Title

We are seeking a seasoned Quality Assurance Specialist to join our engineering team.

The successful candidate will play a pivotal role in ensuring compliance, validation, and quality risk management across various engineering projects and day-to-day operations.

This is an exciting opportunity for a professional with a strong background in quality assurance and a passion for embedding quality into all aspects of engineering.

About the Role

In this key position, you will act as a vital interface between Engineering and Quality functions, ensuring that all systems and processes meet EU GMP standards and are inspection-ready.

Your expertise will be instrumental in supporting engineering activities, providing oversight for equipment qualification, utility validation, and facility modifications.

You will also lead or support investigations related to engineering deviations, non-conformances, and CAPAs, ensuring timely closure and root cause identification.

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 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.
Requirements
  • Degree in Engineering, Life Sciences, or a related technical discipline.
  • 5+ years' experience in a GMP-regulated pharmaceutical, biopharmaceutical, 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.

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