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):
1. Ensure engineering work complies with GMP and site quality standards.
2. Oversee equipment qualification, utility validation, and change controls.
3. Support C&Q lifecycle by reviewing and approving protocols and risk documents.
4. Lead or assist with investigations, CAPAs, and timely issue resolution.
5. Contribute to projects for new equipment, process improvements, and upgrades.
6. Represent Quality in engineering initiatives like reliability and energy upgrades.
7. Help prepare for audits and inspections related to GMP and engineering systems
Knowledge, Skills and Experience Required for the Role:
8. Degree in Engineering, Life Sciences, or related field
9. 5+ years in GMP pharma, biopharma, or med device
10. Strong validation, engineering, and GMP knowledge
11. Experience with C&Q docs, risk-based validation & changes
12. Bonus: Familiar with CMMS, BMS, and automation systems