Senior Global Engineering Specialist - Aseptic

CSL Behring

Not specified; not specified; benefits available v...
7+ years reliability engineering experience
5+ years aseptic manufacturing support
Deep knowledge of gmp and sterility assurance
This role serves as a global Subject Matter Expert responsible for defining and optimizing maintenance strategies for aseptic manufacturing assets to ensure high equipment availability and sterility assurance

Job Summary

  • This role serves as a global Subject Matter Expert responsible for defining and optimizing maintenance strategies for aseptic manufacturing assets to ensure high equipment availability and sterility assurance.
  • The position requires deep technical leadership in managing critical systems such as isolators, RABS, cleanroom HVAC, and sterile utilities while ensuring strict adherence to FDA and EU GMP regulations.
  • CSL Behring is a global biotherapeutics leader employing 32,000 people that values inclusion, belonging, and the use of innovative technologies to deliver lifesaving therapies worldwide.

Matching Summary

This role serves as a global Subject Matter Expert responsible for defining and optimizing maintenance strategies for aseptic manufacturing assets to ensure high equipment availability and sterility assurance.

Salary

Not specified; Not specified; Benefits available via CSL Well-being page

Skills & Requirements

Must-have

  • 7+ years reliability engineering experience
  • 5+ years aseptic manufacturing support
  • Deep knowledge of GMP and sterility assurance
  • Expertise in isolators RABS and HVAC systems
  • Root cause analysis and CAPA implementation
  • Experience with FDA 21 CFR and EU GMP Annex 1

Nice-to-have

  • Six Sigma or Lean principles knowledge
  • Master's degree or MBA preferred
  • Experience facilitating global training programs
  • Strong cross-cultural collaboration skills
  • Innovation mindset for new technologies

Key Requirements

  • Bachelor's degree in engineering required
  • 7+ years in reliability or asset management
  • 5+ years supporting aseptic manufacturing areas
  • Experience managing globally distributed teams
  • Ability to travel globally based on business needs

Work Rights

Not specified

Tailored Resume

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