Senior Manufacturing Engineer I - Fill-Finish

About the role

Biogen is looking for a Senior Manufacturing Engineer I in Athlone to support fill-finish manufacturing operations. The engineer designs, installs and optimises process equipment so that production is reliable, efficient and compliant, leads troubleshooting, supports equipment lifecycle management and drives continuous improvement across aseptic filling, inspection, packaging and related assets. The role also covers validation protocols, qualification and validation activities, and small to medium engineering projects such as new equipment installation and system modifications.

Key responsibilities

• Troubleshoot equipment and process issues, update engineering standards, drawings and technical specifications, and lead investigations and corrective actions.
• Lead equipment projects including technology transfers, capital investments, upgrades and process modifications, and coordinate contractors and cross-functional teams.
• Manage project deliverables, timelines, metrics and reporting, and provide technical input for technology transfer, change controls and validation requirements.
• Author and review validation documentation, project plans and technical reports; approve equipment and automation changes through TrackWise workflows.
• Coordinate equipment and cleaning validation, including protocol development, training, execution, tracking and documentation.
• Design and run validation protocols, support FAT, commissioning, startup and qualification, and maintain training compliance.

Required profile

• Bachelor's degree in Engineering or a related technical discipline.
• Proven experience in a pharmaceutical, biotechnology or highly regulated manufacturing environment.
• Demonstrated hands-on experience supporting an aseptic fill line in a GMP-regulated fill-finish environment, including filling equipment, process systems, troubleshooting, qualification and operational support.
• Strong understanding of GMP requirements and regulatory standards.
• Ability to manage multiple priorities, meet deadlines and work independently while collaborating with cross-functional teams, contractors and external partners.
• Flexible and adaptable, able to support extended hours when required.

Required skills

• 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 and analytical skills, and sound engineering judgment.