Senior Global Engineering Specialist - Bulk

CSL Behring

7+ years reliability engineering experience
Bulk biologics manufacturing expertise
Gmp and fda 21 cfr compliance knowledge
This role serves as a global Subject Matter Expert responsible for defining and optimizing maintenance strategies for critical bulk biotech systems across the asset lifecycle

Job Summary

  • This role serves as a global Subject Matter Expert responsible for defining and optimizing maintenance strategies for critical bulk biotech systems across the asset lifecycle.
  • The position requires deep technical leadership in managing bioreactors, filtration systems, and utilities while ensuring strict adherence to FDA and EU GMP regulations.
  • CSL Behring offers a culture of inclusion and belonging, supporting a diverse workforce that drives innovation in biotherapeutics to save lives globally.

Matching Summary

This role serves as a global Subject Matter Expert responsible for defining and optimizing maintenance strategies for critical bulk biotech systems across the asset lifecycle.

Skills & Requirements

Must-have

  • 7+ years reliability engineering experience
  • Bulk biologics manufacturing expertise
  • GMP and FDA 21 CFR compliance knowledge
  • Bioreactor and chromatography system maintenance
  • Root cause analysis and CAPA implementation

Nice-to-have

  • Six Sigma or Lean principles knowledge
  • Experience with global matrix organizations
  • Strong cross-cultural collaboration skills
  • Innovation mindset for asset performance
  • MBA or Master's degree preferred

Key Requirements

  • Bachelor's degree in Engineering required
  • Master's degree or MBA preferred
  • 5+ years supporting bulk biologics manufacturing
  • Ability to travel globally based on business needs

Work Rights

Not specified

Tailored Resume

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