This role serves as a global Subject Matter Expert responsible for defining and optimizing maintenance strategies for critical bulk biotech systems across the entire 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 entire asset lifecycle.
The position requires deep technical leadership in managing bioreactors, filtration systems, and clean 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 and fostering a culture of inclusion and belonging.
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 entire 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
Global team leadership experience
SAP PM or Maximo CMMS proficiency
Innovation mindset for asset performance
Cross-cultural collaboration skills
Key Requirements
Bachelor's degree in Engineering required
Master's degree or MBA preferred
5+ years supporting bulk biologics manufacturing
Experience with global distributed teams
Ability to travel globally based on business needs