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
courtney.russell@collinsmcnicholas.ie
+353 (0) 71 9108062