This role serves as a global Subject Matter Expert responsible for defining and optimizing maintenance strategies for aseptic manufacturing assets to ensure sterility assurance and regulatory compliance
Job Summary
This role serves as a global Subject Matter Expert responsible for defining and optimizing maintenance strategies for aseptic manufacturing assets to ensure sterility assurance and regulatory compliance.
The position requires extensive experience managing globally distributed teams and influencing senior stakeholders while driving asset lifecycle management and obsolescence planning.
CSL Behring is a global biotherapeutics leader committed to saving lives through innovative therapies and operates one of the world's largest plasma collection networks.
Matching Summary
This role serves as a global Subject Matter Expert responsible for defining and optimizing maintenance strategies for aseptic manufacturing assets to ensure sterility assurance and regulatory compliance.
Skills & Requirements
Must-have
7+ years reliability engineering experience
5+ years aseptic sterile manufacturing support
Deep knowledge of FDA 21 CFR Parts 210/211
Expertise in HVAC HEPA filtration maintenance
Experience with isolators RABS filling lines
Root cause analysis CAPA implementation skills
Nice-to-have
Six Sigma Lean principles knowledge
Global matrix organization influence experience
Cross-cultural collaboration capabilities
Innovation mindset for new technologies
Mentoring site engineers and technical teams
Key Requirements
Bachelor's degree in engineering required
Master's degree or MBA preferred
7+ years in reliability or maintenance engineering
5+ years supporting aseptic manufacturing areas
Ability to travel globally based on business needs