Serve as global SME for maintenance and reliability of bulk biotech manufacturing areas
Develop and maintain global maintenance standards for bulk process equipment, utilities, and support systems
Define preventive, predictive, and condition-based maintenance strategies aligned with GMP and product quality requirements
Lead asset lifecycle management, obsolescence planning, and spare parts strategies for critical bulk manufacturing equipment
Ensure maintenance practices minimize risk to product quality and cross-contamination
Provide technical leadership for maintenance, troubleshooting, and performance optimization of bioreactors, chromatography systems, and filtration systems
Ensure maintenance programs comply with FDA regulations and support qualification activities impacted by maintenance work
Drive root cause analysis and implementation of sustainable CAPAs
Identify and champion continuous improvement initiatives for equipment uptime and reliability
Collaborate with global teams in Quality, MS&T, Automation, Process Engineering, and Operations and mentor site maintenance teams

Bachelor’s degree in Engineering (Mechanical, Chemical, Electrical, Biomedical, or related field)
7+ years of experience in reliability engineering, maintenance engineering, or asset management within a regulated industry
5+ years supporting bulk biologics manufacturing (upstream and/or downstream)
Strong technical capability in root cause analysis, predictive diagnostics, risk management, and equipment lifecycle management.
Innovation mindset that promotes new technologies, advanced diagnostics, and continuous improvement in asset performance.
Ability to travel globally based on business needs.

Senior Global Engineering Specialist – Bulk

Key skills