This role serves as a global Subject Matter Expert responsible for defining and optimizing maintenance strategies for critical bulk biotech manufacturing assets
Job Summary
This role serves as a global Subject Matter Expert responsible for defining and optimizing maintenance strategies for critical bulk biotech manufacturing assets.
The position requires ensuring high equipment availability and process robustness while maintaining strict adherence to FDA and EU GMP regulations.
Candidates will partner with global teams to drive continuous improvement initiatives that enhance Mean Time Between Failures and overall operational efficiency.
Matching Summary
This role serves as a global Subject Matter Expert responsible for defining and optimizing maintenance strategies for critical bulk biotech 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
CMMS/EAM system proficiency
Nice-to-have
Six Sigma or Lean principles knowledge
Global team leadership experience
Predictive maintenance strategy development
Cross-cultural collaboration skills
Innovation mindset for asset performance
Key Requirements
Bachelor's degree in Engineering required
Master's degree or MBA preferred
5+ years supporting bulk biologics manufacturing
Experience managing globally distributed teams
Ability to travel globally based on business needs