This role serves as a global Subject Matter Expert responsible for defining and optimizing maintenance strategies for critical aseptic manufacturing assets
Job Summary
This role serves as a global Subject Matter Expert responsible for defining and optimizing maintenance strategies for critical aseptic manufacturing assets.
The position requires ensuring high equipment availability and sterility assurance while maintaining strict compliance with FDA 21 CFR Parts 210/211 and EU GMP Annex 1.
Candidates will collaborate with global teams to drive continuous improvement initiatives that enhance Mean Time Between Failures (MTBF) and overall operational efficiency.
Matching Summary
This role serves as a global Subject Matter Expert responsible for defining and optimizing maintenance strategies for critical aseptic manufacturing assets.
Skills & Requirements
Must-have
7+ years reliability engineering experience
5+ years aseptic manufacturing support
Deep knowledge of GMP and sterility assurance
Experience with isolators, RABS, and filling lines
HVAC and cleanroom utility maintenance expertise
Root cause analysis and CAPA implementation
Global stakeholder management skills
Nice-to-have
Six Sigma or Lean principles knowledge
Master's degree or MBA preferred
Experience with SAP PM or Maximo systems
Cross-cultural collaboration abilities
Innovation mindset for new technologies
Ability to lead change in matrix organizations
Key Requirements
Bachelor's degree in Mechanical, Electrical, Chemical, or related engineering field
7+ years in reliability or maintenance engineering within regulated industries
5+ years specifically supporting aseptic or sterile manufacturing areas
Extensive experience managing globally distributed technical teams
Proven ability to influence senior stakeholders in complex organizations