About Quality Assurance in a Biologics Environment
A biologics company in the West of Ireland is seeking a Quality Engineer to support engineering projects and daily operations with a focus on compliance, validation, and quality risk.
This role serves as a vital link between Engineering and Quality teams to ensure systems and processes meet EU GMP standards and are inspection-ready.
Your Key Responsibilities:
* Ensure all engineering work complies with GMP and site quality standards.
* You will oversee equipment qualification, utility validation, and change controls.
* Support the 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.
* You will represent Quality in engineering initiatives like reliability and energy upgrades.
* Help prepare for audits and inspections related to GMP and engineering systems.
About You
We are looking for someone with a degree in Engineering, Life Sciences, or a related field, and 5+ years of experience in GMP pharma, biopharma, or med device.
The successful candidate will have strong validation, engineering, and GMP knowledge, as well as experience with C&Q documents, risk-based validation & changes.
Benefits of the Role
This is an excellent opportunity to work with a leading company in the West of Ireland.
The successful candidate will have experience working in a GMP environment and a strong understanding of EU GMP standards.
We are looking for someone who is proactive, flexible, and able to work well in a team.