This role serves as a global Subject Matter Expert responsible for defining and optimizing maintenance strategies for aseptic manufacturing assets to ensure high equipment availability and sterility assurance
Job Summary
This role serves as a global Subject Matter Expert responsible for defining and optimizing maintenance strategies for aseptic manufacturing assets to ensure high equipment availability and sterility assurance.
The position requires deep technical leadership in managing isolators, RABS, filling lines, and critical utilities while ensuring strict adherence to FDA, EU GMP, and ISO standards.
Candidates will collaborate with global teams to drive continuous improvement initiatives, manage deviation investigations, and mentor site engineers to enhance overall operational reliability.
Matching Summary
This role serves as a global Subject Matter Expert responsible for defining and optimizing maintenance strategies for aseptic manufacturing assets to ensure high equipment availability and sterility assurance.
Skills & Requirements
Must-have
Aseptic manufacturing maintenance expertise
GMP and sterility assurance knowledge
HVAC and cleanroom system management
Root cause analysis and CAPA implementation
Global team collaboration and influence
Nice-to-have
Six Sigma or Lean principles experience
Predictive maintenance strategy development
CMMS/EAM system optimization skills
Cross-cultural communication abilities
Innovation mindset for asset performance
Key Requirements
Bachelor's degree in engineering required
7+ years in reliability or maintenance engineering