Serve as global SME for maintenance of aseptic manufacturing areas and sterile assets
Develop and maintain global maintenance standards for aseptic equipment, cleanrooms, HVAC, and critical utilities
Define preventive, predictive, and condition-based maintenance strategies aligned with GMP and sterility assurance requirements
Drive asset lifecycle management, obsolescence planning, and spare parts strategies for critical aseptic systems
Provide technical leadership for maintenance and troubleshooting of aseptic filling lines and support equipment
Ensure maintenance activities preserve cleanroom classification and contamination control
Ensure maintenance programs align with FDA 21 CFR Parts 210/211, EU GMP Annex 1, ISO 14644 and biotech best practices
Support qualification and requalification activities impacted by maintenance interventions (IQ/OQ/PQ)
Act as an engineering SME during regulatory inspections and internal audits
Review and approve maintenance SOPs, change controls, and technical risk assessments
Support corporate responsibility efforts for quality and regulatory compliance

Bachelor’s degree in engineering (Mechanical, Electrical, Chemical, or related)
Master’s degree or MBA preferred
7+ years of experience in reliability engineering, maintenance engineering, or asset management within a manufacturing, pharmaceutical, chemical, or similar regulated industry
5+ years supporting aseptic or sterile manufacturing areas
Extensive experience managing globally distributed teams and influencing senior stakeholders in complex organizations
Deep knowledge of aseptic manufacturing and sterility assurance principles
Maintenance of isolators, RABS, filling lines, and cleanroom systems
HVAC, HEPA filtration, and sterile utilities maintenance impact on contamination control strategies (CCS)
Experience with global or multi-site technical support preferred
Strong technical capability in root cause analysis, predictive diagnostics, risk management, and equipment lifecycle management
Experience facilitating training, workshops, or capability development programs
Ability to travel globally based on business needs
Knowledge of Six Sigma/Lean principles is a plus

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Senior Global Engineering Specialist – Aseptic

Key skills