Quality Engineer - Sligo

Cpl Group

  • Sligo
  • Permanent
  • Full-time
  • 8 days ago
JO-2507-555094Our client - a GMP-regulated biopharmaceutical facility in Sligo, requires a Quality Engineering to join their engineering team. The successful candidate will support 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.Please note - applicants need to have a stamp 4 or to have unrestricted full working rights for IrelandResponsibilities:
  • 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.
Requirements
  • Degree in Engineering, Life Sciences, or a 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.

Cpl Group