Senior Global Engineering Specialist - Fractionation

CSL Behring

Global subject matter expert
Fractionation process equipment support
Utilities and facility systems expertise
Serve as global SME for maintenance and reliability of fractionation biotech manufacturing operations

Job Summary

  • Serve as global SME for maintenance and reliability of fractionation biotech manufacturing operations.
  • Ensure maintenance programs comply with FDA 21 CFR Parts 210/211, EU GMP, and plasma-derived product regulations.
  • Partner with Quality, MS&T, Automation, Process Engineering, and Operations teams globally to drive knowledge sharing and best practice harmonization.

Matching Summary

Serve as global SME for maintenance and reliability of fractionation biotech manufacturing operations.

Skills & Requirements

Must-have

  • Global Subject Matter Expert
  • Fractionation process equipment support
  • Utilities and facility systems expertise
  • Compliance with GMP and viral safety
  • Deviation management and RCA
  • Digital maintenance and CMMS/EAM

Nice-to-have

  • Strategic thinker with proactive approach
  • Innovation mindset for new technologies
  • Cross-cultural collaboration skills
  • Commitment to CSL values
  • Knowledge of Six Sigma/Lean principles

Key Requirements

  • Bachelor’s degree in Engineering
  • 7+ years of experience in reliability engineering
  • 7+ years supporting fractionation manufacturing
  • Extensive experience managing globally distributed teams
  • Ability to travel globally

Work Rights

Not specified

Tailored Resume

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