Senior Global Engineering Specialist - Fractionation
CSL Behring
Fractionation process equipment maintenance
Gmp and fda 21 cfr parts 210/211 compliance
Viral safety and product quality assurance
This role serves as a global Subject Matter Expert responsible for defining and optimizing maintenance strategies for fractionation assets used in plasma-derived biologics production
Job Summary
This role serves as a global Subject Matter Expert responsible for defining and optimizing maintenance strategies for fractionation assets used in plasma-derived biologics production.
The position requires deep technical leadership in managing critical equipment such as centrifuges, precipitation systems, and cold processing utilities while ensuring strict regulatory compliance.
Candidates will drive continuous improvement initiatives to enhance equipment uptime and reliability across a complex global matrix organization.
Matching Summary
This role serves as a global Subject Matter Expert responsible for defining and optimizing maintenance strategies for fractionation assets used in plasma-derived biologics production.
Skills & Requirements
Must-have
Fractionation process equipment maintenance
GMP and FDA 21 CFR Parts 210/211 compliance
Viral safety and product quality assurance
Root cause analysis and CAPA implementation
CMMS/EAM system optimization (SAP PM, Maximo)
ATEX hazardous area equipment knowledge
Cold processing and utility systems expertise
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 thinking for asset lifecycle planning
Key Requirements
Bachelor's degree in Engineering required; Master's preferred
7+ years 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