Senior Global Engineering Specialist - Fractionation
Century Center
Fractionation process equipment expertise
Gmp and fda regulatory compliance knowledge
Viral safety and product quality maintenance
This role serves as the 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 the 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 adherence to GMP and viral safety regulations.
Candidates will drive continuous improvement initiatives across a global network, leveraging data analytics to enhance equipment availability and Mean Time Between Failures (MTBF) while maintaining regulatory compliance.
Matching Summary
This role serves as the 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 expertise
GMP and FDA regulatory compliance knowledge
Viral safety and product quality maintenance
Root cause analysis and CAPA implementation
CMMS/EAM system proficiency (SAP PM/Maximo)
Cold systems and ATEX hazardous area experience
Global team leadership and stakeholder influence
Nice-to-have
Six Sigma or Lean principles application
Predictive diagnostics and advanced analytics
Cross-cultural collaboration skills
Continuous improvement initiative championing
Innovation mindset for new technologies
Key Requirements
Bachelor's degree in Engineering required; Master's preferred
7+ years of experience in reliability or maintenance engineering within regulated industries
7+ years supporting fractionation or plasma-derived biologics manufacturing specifically
Experience managing globally distributed teams and influencing senior stakeholders