Senior Manufacturing Engineer I: Aseptic Fill-Finish

Biogen; Athlone; On-site; EUR 70,000 - 95,000; Full time

Job summary

Biogen in Athlone is seeking a Senior Manufacturing Engineer I to provide engineering support for fill-finish operations, designing, installing, and optimizing process equipment to ensure reliable, compliant production. You will lead validation activities, oversee qualification, prepare technical documentation, and manage equipment projects, coordinating cross-functional teams and external contractors.

This role requires strong GMP knowledge, hands-on troubleshooting, and the ability to drive

Qualifications

• Bachelor's degree in Engineering or a related technical discipline.
• Experience in pharmaceutical/biotech regulated manufacturing.
• Hands-on engineering supporting aseptic fill lines in GMP environments.
• Strong GMP knowledge and regulatory standards.
• Proficiency with MS Office (Excel, Word, PowerPoint, Project).
• Excellent communication and ability to work across teams.
• Ability to manage multiple priorities and meet deadlines.
• Flexible to support extended hours when required.

Responsibilities

• Provide engineering support for fill-finish operations and process equipment.
• Lead and support equipment-related projects including tech transfers and equipment upgrades.
• Coordinate validation efforts, qualification, and documentation.
• Manage project timelines, milestones, and reporting for successful execution.
• Approve changes via TrackWise workflows and manage deviations.
• Coordinate equipment and cleaning validation activities and protocols.
• Design and execute validation protocols and provide technical input for transfer activities.
• Support FAT, commissioning, startup, and qualification efforts.
• Collaborate with cross-functional teams to drive process improvements.

Skills

GMP compliance

Root cause analysis

Project management

Problem solving

Cross-functional collaboration

Mentoring junior engineers

Education

Bachelor's degree in Engineering or related technical discipline

Tools

PCS & DCS

Job description

Biogen in Athlone is seeking a Senior Manufacturing Engineer I to provide engineering support for fill-finish operations, designing, installing, and optimizing process equipment to ensure reliable, compliant production. You will lead validation activities, oversee qualification, prepare technical documentation, and manage equipment projects, coordinating cross-functional teams and external contractors.

This role requires strong GMP knowledge, hands-on troubleshooting, and the ability to drive