
Senior Quality Engineer Position Available
2 weeks ago
We are seeking a Quality Assurance Professional to join our Engineering team at a GMP-regulated biopharmaceutical facility in Ireland.
Key Responsibilities:- Ensure all engineering activities are carried out in compliance with GMP and site quality standards.
- Provide oversight for equipment qualification, utility validation, facility modifications, and engineering change controls.
- Support the commissioning and qualification 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 (e.g. HPRA) 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.
Requirements:
- Degree in Engineering, Life Sciences, or related technical discipline.
- 5+ years experience in a GMP-regulated pharmaceutical, biopharma, or medical device environment.
- Strong knowledge of validation principles, engineering best practices, and regulatory requirements under GMP.
- Hands-on experience with C&Q documentation, risk-based validation, and change management processes.
- Familiarity with engineering systems such as CMMS and automated manufacturing equipment is a plus.
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