This role serves as a global Subject Matter Expert responsible for defining and optimizing maintenance strategies for bulk biologics manufacturing assets across upstream and downstream operations
Job Summary
This role serves as a global Subject Matter Expert responsible for defining and optimizing maintenance strategies for bulk biologics manufacturing assets across upstream and downstream operations.
The position requires ensuring high equipment availability and regulatory compliance while supporting safe, efficient manufacturing throughout the asset lifecycle.
CSL Behring is a global biotherapeutics leader driven by a promise to save lives, employing over 32,000 people and delivering therapies to more than 100 countries.
Matching Summary
This role serves as a global Subject Matter Expert responsible for defining and optimizing maintenance strategies for bulk biologics manufacturing assets across upstream and downstream operations.
Skills & Requirements
Must-have
7+ years reliability engineering experience
5+ years bulk biologics manufacturing support
Deep knowledge of USP/DSP processes
Maintenance of bioreactors and chromatography systems
Expertise in CIP/SIP systems and utilities
FDA 21 CFR Parts 210/211 and EU GMP compliance
Root cause analysis and CAPA implementation
Nice-to-have
Six Sigma or Lean principles knowledge
Experience with global multi-site technical support
Innovation mindset for advanced diagnostics
Ability to lead change in complex matrix organizations
Cross-cultural collaboration skills
Key Requirements
Bachelor's degree in Engineering required
Master's degree or MBA preferred
7+ years in reliability or maintenance engineering