Quality Engineer

Collins McNicholas Recruitment; Sligo; On-site; EUR 60,000 - 75,000; Full time

Job summary

A leading recruitment company in Sligo is seeking a Quality Engineer to join a Biologics Company in the West of Ireland. This role focuses on compliance, validation, and quality risk, serving as a link between Engineering and Quality teams to ensure systems meet EU GMP standards. The ideal candidate will have over 5 years of experience in GMP environments and a degree in Engineering or Life Sciences.

Qualifications

• 5+ years of experience in GMP pharma, biopharma, or medical devices.
• Strong knowledge of validation, engineering, and GMP.
• Experience with C&Q documents, risk-based validation, and changes.

Responsibilities

• Ensure engineering work complies with GMP and quality standards.
• Oversee equipment qualification and utility validation.
• Lead investigations and timely issue resolution.

Skills

GMP compliance

Validation

Quality risk management

Engineering knowledge

Education

Degree in Engineering, Life Sciences, or related field

Tools

CMMS

BMS

Automation systems

Job description

Overview

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.

Responsibilities

• 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

• 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

Contact

For a confidential discussion and more information on the role contact Courtney Russell

[e-mail]

[phone]