Aseptic Operations Engineer

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Ireland

Ireland

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GerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services. We partner with many of the world's largest life science & technology companies who entrust in us to deliver their most strategic and important projects. Job Title: Aseptic Operations Engineer Location: Sligo, Ireland (On-site) In this role, you will ensure that all aseptic manufacturing equipment, cleanrooms, and utility systems are designed, operated, and maintained to the highest industry standards and GMP regulations. Key Responsibilities System Monitoring & Performance: Conduct real-time monitoring and trending of cleanroom performance (temp, RH, pressure, airflow), critical utility performance, and equipment cycles (CIP, SIP, VHP, Autoclaves, Lyophilization). Investigation & Troubleshooting: Lead engineering-related troubleshooting and actively support investigations into sterility, media fills, EM excursions, and EMPQ to establish root causes and execute CAPAs. Compliance & Design: Ensure cleanroom and utility designs comply with standards and global GMP regulations. Manage and approve PM strategies, automation alarm criticality ranking, and site Change Controls. Cross-Functional Collaboration: Partner with Quality, Operations, and MQA teams to support manufacturing shifts, ensure product sterility, and contribute to the site Contamination Control Strategy. Continuous Improvement: Lead engineering projects and initiatives that drive continuous improvement, risk management, and a high-performance safety culture on site. Act as the engineering SME during regulatory audits. Qualifications & Experience Education: Third-level degree in Engineering or an equivalent technical discipline. Experience: 3+ years of experience in a GMP environment, with at least 1+ years directly supporting Aseptic Manufacturing. Knowledge: Strong understanding of global aseptic regulatory requirements and risk management tools. Skills: Proven project management capabilities and excellent cross-functional communication skills. #Gertek To start the process click the Continue to Application or Login/Register to apply button below.

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