This role serves as a global Subject Matter Expert responsible for defining and optimizing maintenance strategies for critical bulk biologics manufacturing assets across upstream and downstream operations
Job Summary
This role serves as a global Subject Matter Expert responsible for defining and optimizing maintenance strategies for critical bulk biologics manufacturing assets across upstream and downstream operations.
The position requires ensuring high equipment availability and regulatory compliance while supporting safe, efficient manufacturing throughout the entire asset lifecycle.
Candidates will partner with global teams to drive continuous improvement initiatives that enhance equipment uptime, reliability metrics like MTBF, and overall maintenance efficiency.
Matching Summary
This role serves as a global Subject Matter Expert responsible for defining and optimizing maintenance strategies for critical bulk biologics manufacturing assets across upstream and downstream operations.
Skills & Requirements
Must-have
7+ years reliability engineering experience
5+ years bulk biologics manufacturing support
Deep knowledge of USP/DSP processes
Maintenance of bioreactors and chromatography systems
Regulatory compliance with FDA 21 CFR and EU GMP
Root cause analysis and CAPA implementation
Global team collaboration and mentoring
Nice-to-have
Six Sigma or Lean principles knowledge
Experience with SAP PM or Maximo CMMS
Master's degree or MBA preferred
Innovation mindset for new technologies
Cross-cultural collaboration skills
Strategic thinking and proactive problem-solving
Executive-level communication capabilities
Key Requirements
Bachelor's degree in Engineering required
7+ years in reliability or maintenance engineering
5+ years in bulk biologics manufacturing
Experience managing globally distributed teams
Ability to travel globally based on business needs