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 critical systems including isolators, RABS, cleanroom HVAC, and utilities while ensuring strict compliance with FDA 21 CFR Parts 210/211 and EU GMP Annex 1.
CSL Behring is a global biotherapeutics leader committed to saving lives through innovative therapies, offering a culture that values inclusion, belonging, and diverse workforce perspectives.
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
7+ years reliability engineering experience
5+ years aseptic sterile manufacturing support
Deep knowledge of GMP and sterility assurance
Experience with isolators RABS and filling lines
HVAC HEPA filtration and cleanroom systems expertise
Root cause analysis and CAPA implementation skills
CMMS/EAM system deployment experience
Nice-to-have
Six Sigma Lean principles knowledge
Master's degree or MBA preferred
Cross-cultural collaboration capabilities
Innovation mindset for new technologies
Ability to lead change in matrix organizations
Executive-level communication skills
Experience facilitating training workshops
Key Requirements
Bachelor's degree in engineering required
7+ years in reliability or maintenance engineering