Senior Global Engineering Specialist – Aseptic
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 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
Requirements
- 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
Benefits
- For more information on CSL benefits visit How CSL Supports Your Well-being | CSL
- You Belong at CSL
- At CSL, Inclusion and Belonging is at the core of our mission and who we are
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
aseptic manufacturingsterile assets maintenancepreventive maintenancepredictive maintenancecondition-based maintenanceasset lifecycle managementroot cause analysispredictive diagnosticsrisk managementequipment lifecycle management
Soft Skills
technical leadershipinfluencing senior stakeholdersmanaging globally distributed teamsfacilitating trainingworkshopscapability development
Certifications
Bachelor’s degree in engineeringMaster’s degreeMBASix SigmaLean principles