Quality Engineer (Sligo)
About Your New Employer
* Join a leading biopharmaceutical company with a strong commitment to quality and innovation.
* Work in a dynamic and collaborative environment that values professional growth and development.
* Be part of a team dedicated to ensuring the highest standards of GMP and GDP compliance.
About Your New Job
* Ensure engineering activities are carried out in compliance with GMP and site quality engineering standards.
* Provide oversight for equipment qualification, utility validation, facility modifications, and engineering change controls.
* Support the commissioning and qualification (C&Q) lifecycle, including document review and approval of protocols (IQ/OQ/PQ), risk assessments, and summary reports.
* Lead or support investigations related to engineering deviations, non-conformances, and CAPAs ensuring timely closure and root cause identification.
* Participate in cross-functional project teams for new equipment introduction, process improvements, and site upgrades, ensuring quality is embedded throughout.
* Act as quality representative within engineering-led initiatives (e.g., reliability improvements, energy efficiency upgrades).
* Support preparation for regulatory inspections and internal audits relating to engineering systems and GMP compliance.
* Maintain and improve engineering quality processes, such as document control, calibration systems, and preventative maintenance compliance.
What Skills You Need
* Strong understanding of QA expectations (deviations, CAPAs, change control), GMP, and GDP.
* Proven ability to work effectively on their own initiative as well as effectively contributing to the team environment.
* Experience working in a matrix role bridging Engineering and Quality departments.
* Knowledge of ISPE Baseline Guides, GAMP 5, and data integrity best practices.
* Six Sigma / Lean certification is advantageous.
What’s on Offer
* Competitive salary and comprehensive benefits package.
* Opportunities for professional development and career advancement.
* A supportive and inclusive work environment that values innovation and excellence.
What’s Next
Apply now by clicking the “Apply Now" button or call me, Ross Keyes on 091749269. Or if the job isn’t quite right but you are looking for something similar, please get in touch. We also have multiple Temp, FTC, and Contract jobs available.
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