Aseptic Operations Engineer

Aseptic Operations Engineer

AbbVie

Sligo, Ireland

About the Role:

As an Aseptic Operations Engineer and part of the Aseptic Operations function, you will act as an Aseptic Manufacturing SME, ensuring equipment, cleanroom, and utility systems are designed and operated according to AbbVie standards and best practices. You’ll collaborate with cross-functional site colleagues and help foster a high-performance culture focused on continuous improvement and aseptic excellence.

Key Responsibilities:

• Serve as Subject Matter Expert for all equipment, cleanroom, and utility systems supporting aseptic manufacturing;
• Ensure all related systems are compliant with safety, environmental, aseptic, GMP, and regulatory requirements, as well as Network Best Practice;
• Support operations through real-time monitoring of cleanroom and utility system performance, and critical equipment cycles (e.g., CIP, SIP, VHP, aseptic filling, autoclaves, lyophilization, depyrogenation, heat sterilization);
• Investigate and address automation alarms and proactively trend system performance, developing action plans as needed;
• Partner with Quality, Operations, MQA, and Aseptic mentors to deliver safe, quality, and timely product batches, assuring sterility at every step;
• Participate in troubleshooting and investigations for equipment, cleanroom, and utility events, working to establish root cause and support CAPA;
• Drive continuous improvement by assessing and implementing new regulations, best practices, and process enhancements within Aseptic Manufacturing Engineering;
• Provide key input into the design of engineering systems; ensure alignment with AbbVie standards and lead projects related to equipment and utility changes;
• Approve preventative maintenance strategies, rank alarms by criticality, and ensure robust change control and risk management procedures;
• Act as SME during regulatory audits and actively support contamination control and sterility assurance initiatives;
• Promote a speak-up, high-performance culture through leadership, engagement, and participation in manufacturing and testing GEMBAs.

Qualifications:

• Third Level Degree in an Engineering or equivalent discipline;
• 3+ Years of experience in a GMP Environment with 1+ years of experience in support of Aseptic Manufacturing;
• Strong knowledge of Regulatory Requirements;
• Project Management experience;
• Excellent communication skills.