Serve as global Subject Matter Expert (SME) responsible for defining, standardizing, and optimizing maintenance and reliability strategies for aseptic manufacturing assets across biotech facilities
Job Summary
Serve as global Subject Matter Expert (SME) responsible for defining, standardizing, and optimizing maintenance and reliability strategies for aseptic manufacturing assets across biotech facilities.
Ensure high equipment availability, sterility assurance, and regulatory compliance for critical aseptic systems while supporting safe, compliant, and efficient operations throughout the asset lifecycle.
Collaborate with Quality, Validation, MS&T, Automation, and Operations teams globally, mentoring and coaching site engineers and technical teams.
Matching Summary
Serve as global Subject Matter Expert (SME) responsible for defining, standardizing, and optimizing maintenance and reliability strategies for aseptic manufacturing assets across biotech facilities.
Skills & Requirements
Must-have
Aseptic manufacturing and sterility assurance
Maintenance of isolators, RABS, filling lines
Cleanroom HVAC and sterile utilities maintenance
Global technical support and leadership
Root cause analysis and risk management
Nice-to-have
Strategic thinker with proactive approach
Innovation mindset for new technologies
Cross-cultural collaboration skills
Executive-level communication skills
Six Sigma/Lean principles knowledge
Key Requirements
Bachelor’s degree in engineering
7+ years of experience in reliability engineering, maintenance engineering, or asset management
5+ years supporting aseptic or sterile manufacturing areas