Senior Global Engineering Specialist - Fractionation
CSL Behring
Fractionation process equipment maintenance
Gmp and viral safety compliance expertise
Root cause analysis and capa implementation
This role serves as the global Subject Matter Expert responsible for defining and optimizing maintenance strategies for fractionation assets in plasma-derived biologics production
Job Summary
This role serves as the global Subject Matter Expert responsible for defining and optimizing maintenance strategies for fractionation assets in plasma-derived biologics production.
The position requires deep technical leadership in managing critical equipment such as precipitation systems, centrifuges, and large-volume vessels while ensuring strict adherence to FDA and EU GMP regulations.
Candidates will partner with global teams to drive continuous improvement initiatives that enhance equipment uptime, yield, and product quality across a complex international network.
Matching Summary
This role serves as the global Subject Matter Expert responsible for defining and optimizing maintenance strategies for fractionation assets in plasma-derived biologics production.
Skills & Requirements
Must-have
Fractionation process equipment maintenance
GMP and viral safety compliance expertise
Root cause analysis and CAPA implementation
Centrifuge and cold system troubleshooting
ATEX hazardous area equipment knowledge
CMMS/EAM system optimization experience
Nice-to-have
Six Sigma or Lean principles application
Cross-cultural global team collaboration
Innovation mindset for advanced diagnostics
Mentoring and technical coaching skills
Strategic influence without authority
Key Requirements
Bachelor's degree in Engineering required; Master's preferred
7+ years of experience in reliability or maintenance engineering
7+ years supporting fractionation or plasma-derived biologics manufacturing
Experience managing globally distributed teams
Strong capability in root cause analysis and risk management