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 isolators, RABS, filling lines, and critical utilities while ensuring strict adherence to FDA 21 CFR Parts 210/211 and EU GMP Annex 1 regulations.
CSL Behring is a global biotherapeutics leader committed to saving lives through innovative therapies, offering a culture of inclusion, belonging, and cross-functional collaboration across more than 100 countries.
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.
Skills & Requirements
Must-have
Aseptic manufacturing maintenance expertise
GMP and sterility assurance knowledge
HVAC and cleanroom system management
Root cause analysis and CAPA implementation
Global team collaboration and mentoring
Nice-to-have
Six Sigma or Lean principles experience
Digital maintenance system optimization
Cross-cultural communication skills
Innovation mindset for new technologies
Key Requirements
Bachelor's degree in Engineering required
7+ years in reliability or maintenance engineering