Senior Global Engineering Specialist - Aseptic

CSL Behring

Not specified
Aseptic manufacturing maintenance expertise
Gmp and sterility assurance knowledge
Hvac and cleanroom system management
CSL Behring is seeking a Senior Global Engineering Specialist - Aseptic to serve as a global Subject Matter Expert in the maintenance and reliability of aseptic manufacturing assets. The ideal candidate will have extensive experience in aseptic systems, regulatory compliance, and global team management, while the role offers opportunities for technical leadership and continuous improvement within a diverse and innovative company

Job Summary

  • This role serves as a global Subject Matter Expert responsible for defining and optimizing maintenance strategies for critical aseptic manufacturing assets to ensure sterility assurance and regulatory compliance.
  • The position requires deep technical leadership in managing isolators, RABS, filling lines, and HVAC systems while supporting qualification activities and acting as an engineering SME during regulatory inspections.
  • CSL Behring is a global biotherapeutics leader committed to saving lives through innovative therapies, offering a culture of inclusion, belonging, and cross-functional collaboration across more than 100 countries.

Matching Summary

Match Score: 85

CSL Behring is seeking a Senior Global Engineering Specialist - Aseptic to serve as a global Subject Matter Expert in the maintenance and reliability of aseptic manufacturing assets. The ideal candidate will have extensive experience in aseptic systems, regulatory compliance, and global team management, while the role offers opportunities for technical leadership and continuous improvement within a diverse and innovative company.

Skills & Requirements

Must-have

  • Aseptic manufacturing maintenance expertise
  • GMP and sterility assurance knowledge
  • HVAC and cleanroom system management
  • Root cause analysis and CAPA implementation
  • Global team collaboration and mentorship
  • CMMS/EAM system optimization experience

Nice-to-have

  • Six Sigma or Lean principles application
  • Innovation mindset for new technologies
  • Cross-cultural communication skills
  • Experience with predictive diagnostics
  • Strategic portfolio management background

Key Requirements

  • Bachelor's degree in engineering required
  • 7+ years in reliability or maintenance engineering
  • 5+ years supporting aseptic manufacturing areas
  • Experience managing globally distributed teams
  • Deep knowledge of FDA 21 CFR and EU GMP Annex 1

Work Rights

Not specified

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