Quality Engineer

Collins McNicholas

  • Sligo
  • Permanent
  • Full-time
  • 1 month ago
Excellent opportunity for a Quality Engineer to join a Biologics Company in the West of Ireland. The Quality Engineer supports engineering projects and daily operations with a focus on compliance, validation, and quality risk. It serves as a vital link between Engineering and Quality teams to ensure systems and processes meet EU GMP standards and are inspection-ready.Overview of your responsibilities (full job description available on request):
  • Ensure engineering work complies with GMP and site quality standards.
  • Oversee equipment qualification, utility validation, and change controls.
  • Support C&Q lifecycle by reviewing and approving protocols and risk documents.
  • Lead or assist with investigations, CAPAs, and timely issue resolution.
  • Contribute to projects for new equipment, process improvements, and upgrades.
  • Represent Quality in engineering initiatives like reliability and energy upgrades.
  • Help prepare for audits and inspections related to GMP and engineering systems
Knowledge, Skills and Experience Required for the Role:
  • Degree in Engineering, Life Sciences, or related field
  • 5+ years in GMP pharma, biopharma, or med device
  • Strong validation, engineering, and GMP knowledge
  • Experience with C&Q docs, risk-based validation & changes
  • Bonus: Familiar with CMMS, BMS, and automation systems
For a confidential discussion and more information on the role contact Courtney Russell+353 (0) 71 9108062

Collins McNicholas