Senior Aseptic Manufacturing Engineer

Biogen, Inc.

Athlone

On-site

EUR 70,000 - 95,000

Full time

34 hours ago
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Job summary

Biogen, Inc. is seeking a Senior Manufacturing Engineer I to provide engineering support for fill-finish manufacturing operations, designing, installing, and optimizing process equipment to ensure reliable, efficient, and compliant production.

You will lead troubleshooting, validation activities, equipment lifecycle management, technology transfers, and cross-functional collaboration, with responsibility for project delivery, FAT, commissioning, and validation documentation.

Qualifications

  • Bachelor's degree in Engineering or related technical discipline.
  • Pharma/biotech GMP experience.
  • Hands-on aseptic fill line support incl. filling equipment, qualification.
  • Strong GMP/regulatory knowledge.
  • Knowledge of Process Control Systems (PCS) and Distributed Control Systems (DCS).
  • MS Office proficiency (Excel/Word/PowerPoint/Project).
  • Strong problem-solving and analytical skills.
  • Understanding of manufacturing processes, equipment lifecycle, and validation activities.
  • Excellent verbal and written communication; cross-functional collaboration.
  • Ability to manage multiple priorities and meet deadlines in a fast-paced environment.

Responsibilities

  • Provide engineering support for fill-finish processes and equipment.
  • Lead equipment lifecycle management and validation activities.
  • Design, install, and optimize process equipment.
  • Coordinate technology transfers, capital investments, and upgrades.
  • Support FAT, commissioning, startup and qualification efforts.
  • Prepare validation documentation and change controls.
  • Collaborate with cross-functional teams to implement process improvements.
  • Manage project deliverables, timelines, metrics and reporting.
  • Maintain training compliance and quality processes.

Skills

Problem solving
Analytical skills
Project management
Cross-functional collaboration
Regulatory compliance
Mentoring
Communication
Independence

Education

Bachelor's degree in Engineering

Tools

PCS
DCS
MS Office
Project

Job description

Biogen, Inc. is seeking a Senior Manufacturing Engineer I to provide engineering support for fill-finish manufacturing operations, designing, installing, and optimizing process equipment to ensure reliable, efficient, and compliant production.

You will lead troubleshooting, validation activities, equipment lifecycle management, technology transfers, and cross-functional collaboration, with responsibility for project delivery, FAT, commissioning, and validation documentation.

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