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 to ensure high equipment availability, process robustness, and strict adherence to regulatory standards like FDA 21 CFR and EU GMP Annex 1.
Candidates will partner with global teams to drive continuous improvement initiatives that enhance Mean Time Between Failures while maintaining critical viral safety and yield requirements.
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 deployment and optimization
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
Data-driven predictive maintenance strategies
Key Requirements
Bachelor's degree in Engineering (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