Senior Global Engineering Specialist - Aseptic

CSL Behring

Multiple Locations
On-site
Aseptic manufacturing and sterility assurance
Maintenance of isolators, rabs, filling lines
Cleanroom hvac and sterile utilities maintenance
CSL Behring is seeking a Senior Global Engineering Specialist - Aseptic who will act as a Subject Matter Expert (SME) for maintaining aseptic manufacturing assets across biotech facilities. The role focuses on optimizing maintenance strategies, ensuring sterility, and driving compliance in aseptic systems while collaborating with global teams

Job Summary

  • Serve as global SME for maintenance of aseptic manufacturing areas and sterile assets, developing and maintaining global maintenance standards for critical equipment.
  • Ensure maintenance programs align with regulatory requirements (FDA, EU GMP, ISO) and support qualification/requalification activities, acting as an engineering SME during inspections.
  • Collaborate with global teams, mentor site engineers, and drive continuous improvement initiatives to enhance equipment uptime, reliability, and maintenance efficiency while maintaining GMP compliance.

Matching Summary

Match Score: 85

CSL Behring is seeking a Senior Global Engineering Specialist - Aseptic who will act as a Subject Matter Expert (SME) for maintaining aseptic manufacturing assets across biotech facilities. The role focuses on optimizing maintenance strategies, ensuring sterility, and driving compliance in aseptic systems while collaborating with global teams.

Skills & Requirements

Must-have

  • Aseptic manufacturing and sterility assurance
  • Maintenance of isolators, RABS, filling lines
  • Cleanroom HVAC and sterile utilities maintenance
  • Root cause analysis and CAPA implementation
  • Global maintenance standards development

Nice-to-have

  • Six Sigma/Lean principles
  • Innovation mindset
  • Cross-cultural collaboration skills
  • Data-informed decision-making

Key Requirements

  • Bachelor’s degree in engineering
  • 7+ years of experience in reliability/maintenance engineering
  • 5+ years supporting aseptic or sterile manufacturing
  • Experience managing globally distributed teams
  • Ability to travel globally

Work Rights

Not specified

Tailored Resume

Cover Letter