This role serves as a global Subject Matter Expert responsible for defining and optimizing maintenance strategies for critical bulk biologics manufacturing assets
Job Summary
This role serves as a global Subject Matter Expert responsible for defining and optimizing maintenance strategies for critical bulk biologics manufacturing assets.
The position requires deep technical leadership in managing bioreactors, chromatography skids, and utility systems 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, reliability, and process robustness across the asset lifecycle.
Matching Summary
This role serves as a global Subject Matter Expert responsible for defining and optimizing maintenance strategies for critical bulk biologics manufacturing assets.
Skills & Requirements
Must-have
7+ years reliability engineering experience
Bulk biologics manufacturing expertise
GMP regulatory compliance knowledge
Root cause analysis and CAPA implementation
Bioreactor and chromatography system maintenance
Global team collaboration and mentoring
Nice-to-have
Six Sigma or Lean principles knowledge
Advanced predictive maintenance strategies
Cross-cultural communication skills
Experience with SAP PM or Maximo CMMS
Master's degree or MBA preferred
Key Requirements
Bachelor's degree in Engineering required
7+ years in reliability or maintenance engineering