Senior Global Engineering Specialist – Bulk
CSL
full-time
Posted on:
Location Type: Hybrid
Location: King of Prussia • Illinois • Pennsylvania • United States
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Job Level
About the role
- 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
Requirements
- 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.
Benefits
- Health insurance
- Flexible work arrangements
- Professional development opportunities
- Inclusion and Belonging programs
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
reliability engineeringmaintenance engineeringasset managementroot cause analysispredictive diagnosticsrisk managementequipment lifecycle managementpreventive maintenancepredictive maintenancecondition-based maintenance
Soft Skills
technical leadershipcollaborationmentoringinnovation mindsetcontinuous improvement