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 including isolators, RABS, cleanroom HVAC, and utilities while ensuring strict adherence to FDA and EU GMP regulations.
  • CSL Behring is a global biotherapeutics leader committed to saving lives through innovative therapies, offering a culture that values inclusion, belonging, and diverse workforce perspectives.

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 portal

Skills & Requirements

Must-have

  • 7+ years reliability engineering experience
  • 5+ years aseptic manufacturing support
  • Deep knowledge of GMP and sterility assurance
  • Experience with isolators RABS and filling lines
  • HVAC and critical utilities maintenance expertise
  • Root cause analysis and CAPA implementation
  • Global stakeholder management skills

Nice-to-have

  • Six Sigma or Lean principles knowledge
  • Master's degree or MBA preferred
  • Experience with SAP PM or Maximo systems
  • Cross-cultural collaboration abilities
  • Innovation mindset for new technologies
  • Ability to travel globally as needed

Key Requirements

  • Bachelor's degree in engineering required
  • 7+ years in reliability or asset management
  • 5+ years supporting aseptic sterile areas
  • Experience managing globally distributed teams
  • Knowledge of FDA 21 CFR Parts 210/211
  • Familiarity with ISO 14644 standards

Work Rights

Not specified

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