The Senior Global Engineering Specialist – Aseptic serves as a global Subject Matter Expert ensuring high equipment availability, sterility assurance, and regulatory compliance for critical aseptic systems
Job Summary
The Senior Global Engineering Specialist – Aseptic serves as a global Subject Matter Expert ensuring high equipment availability, sterility assurance, and regulatory compliance for critical aseptic systems.
This role involves collaboration with multiple global teams, mentoring engineers, and driving continuous improvement initiatives to enhance equipment uptime and maintenance efficiency.
CSL is a global biotherapeutics leader committed to inclusion, innovation, and delivering lifesaving therapies with a diverse workforce and strong ethical values.
Matching Summary
The Senior Global Engineering Specialist – Aseptic serves as a global Subject Matter Expert ensuring high equipment availability, sterility assurance, and regulatory compliance for critical aseptic systems.
Skills & Requirements
Must-have
Maintenance of aseptic manufacturing equipment
Sterility assurance and contamination control
Global maintenance standards development
Root cause analysis and CAPA implementation
Regulatory compliance with GMP and FDA
Technical leadership in aseptic systems
Asset lifecycle and obsolescence management
Nice-to-have
Six Sigma/Lean principles knowledge
Cross-cultural collaboration skills
Executive-level communication skills
Innovation mindset and problem-solving
Mentoring and coaching site engineers
Experience with CMMS/EAM systems
Key Requirements
Bachelor’s degree in engineering
7+ years reliability or maintenance engineering experience
5+ years supporting aseptic or sterile manufacturing
Experience managing global teams and influencing stakeholders
Knowledge of FDA 21 CFR Parts 210/211 and EU GMP Annex 1