Senior Global Engineering Specialist - Aseptic

CSL Behring

Aseptic manufacturing maintenance
Sterility assurance principles
Cleanroom hvac systems
Serve as global SME for maintenance of aseptic manufacturing areas and sterile assets, developing and maintaining global maintenance standards for aseptic equipment, cleanrooms, HVAC, and critical utilities

Job Summary

  • Serve as global SME for maintenance of aseptic manufacturing areas and sterile assets, developing and maintaining global maintenance standards for aseptic equipment, cleanrooms, HVAC, and critical utilities.
  • Ensure maintenance programs align with FDA 21 CFR Parts 210/211, EU GMP Annex 1, ISO 14644, and biotech best practices, acting as an engineering SME during regulatory inspections and internal audits.
  • Collaborate with Quality, Validation, MS&T, Automation, and Operations teams globally, mentoring and coaching site engineers and technical teams, and sharing best practices across the global network.

Matching Summary

Serve as global SME for maintenance of aseptic manufacturing areas and sterile assets, developing and maintaining global maintenance standards for aseptic equipment, cleanrooms, HVAC, and critical utilities.

Skills & Requirements

Must-have

  • Aseptic manufacturing maintenance
  • Sterility assurance principles
  • Cleanroom HVAC systems
  • Critical utilities maintenance
  • Root cause analysis
  • Global matrix leadership

Nice-to-have

  • Strategic thinker
  • Innovation mindset
  • Cross-cultural collaboration
  • Six Sigma/Lean principles

Key Requirements

  • Bachelor’s degree in engineering
  • 7+ years of experience
  • 5+ years supporting aseptic areas
  • Experience managing globally distributed teams
  • Ability to travel globally

Work Rights

Not specified

Tailored Resume

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