Senior Global Engineering Specialist - Fractionation
CSL SEQIRUS
Fractionation process equipment maintenance
Gmp and viral safety compliance
Root cause analysis and capa implementation
This role serves as a 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 a 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 on critical equipment including centrifuges, precipitation systems, and cold processing utilities while ensuring strict adherence to FDA and EU GMP regulations.
Candidates must demonstrate the ability to lead continuous improvement initiatives, manage deviation investigations, and collaborate across a complex global matrix of stakeholders.
Matching Summary
This role serves as a 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
Root cause analysis and CAPA implementation
Centrifuge and cold system expertise
ATEX hazardous area knowledge
CMMS/EAM system proficiency
Nice-to-have
Six Sigma or Lean principles
Cross-cultural collaboration skills
Innovation mindset for new technologies
Mentoring global teams
Data-driven predictive maintenance
Key Requirements
Bachelor's degree in Engineering required
7+ years experience in reliability or maintenance engineering
7+ years supporting fractionation or plasma-derived biologics