Senior Manufacturing Engineer I (Biotechnology)

Location: On campus in Athlone, Ireland

Company

A global biotechnology company developing life-changing medicines with a focus on scientific excellence, inclusion, and operational impact.

What you will do

• Provide engineering support for fill-finish manufacturing, including aseptic filling, component preparation, visual inspection, and container closure systems.
• Troubleshoot equipment and process issues, investigate root causes, identify system improvements, and update engineering standards, drawings, and technical specifications.
• Lead equipment-related projects involving technology transfers, capital investments, equipment upgrades, process modifications, commissioning, startup, and qualification.
• Develop, execute, and coordinate equipment and cleaning validation protocols, training, tracking, documentation, and final technical reports.
• Manage project deliverables, timelines, metrics, reporting, contractors, change controls, deviations, and TrackWise approvals for equipment and automation changes.
• Collaborate with cross-functional teams to implement process improvements, maintain compliance activities, and support manufacturing performance and operational excellence.

Requirements

• Bachelor’s degree in Engineering or a related technical discipline.
• Experience in pharmaceutical, biotechnology, or highly regulated manufacturing environments.
• Hands-on experience supporting an aseptic fill line in a GMP-regulated fill-finish manufacturing environment, including filling equipment, associated process systems, troubleshooting, qualification, and operational support.
• Strong understanding of GMP requirements and applicable regulatory standards.
• Working knowledge of Process Control Systems (PCS) and Distributed Control Systems (DCS).
• Proficiency in Microsoft Office Suite, including Excel, Word, PowerPoint, and Project.
• Strong problem-solving, analytical, communication, organizational, and engineering judgment skills, including the ability to investigate complex issues and resolve deviations.
• Understanding of manufacturing processes, engineering systems, equipment lifecycle management, and validation activities.
• Ability to collaborate across functions, manage multiple priorities, meet deadlines, deliver results in a fast-paced environment, and support extended hours when required.

Culture & Benefits

• Work in an inclusive environment focused on belonging, diverse perspectives, and collaboration.
• Access opportunities for learning, growth, and skills development.
• Work within a well-established biotechnology organization offering stability and resources.
• Contribute to the development and delivery of life-changing medicines.