Senior Global Engineering Specialist - Bulk

CSL Behring

Global sme for bulk biologics maintenance
Define global maintenance standards
Bulk process equipment and systems support
Serve as global SME for maintenance and reliability of bulk biotech manufacturing areas (upstream and downstream)

Job Summary

  • Serve as global SME for maintenance and reliability of bulk biotech manufacturing areas (upstream and downstream).
  • Ensure maintenance programs comply with FDA 21 CFR Parts 210/211, EU GMP, and ICH guidelines.
  • 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 bulk biotech manufacturing areas (upstream and downstream).

Skills & Requirements

Must-have

  • Global SME for bulk biologics maintenance
  • Define global maintenance standards
  • Bulk process equipment and systems support
  • Utilities for bulk biotech operations
  • Compliance with GMP and regulatory expectations
  • Root cause analysis and CAPA implementation
  • Digital maintenance and performance monitoring

Nice-to-have

  • Strategic thinker with proactive approach
  • Innovation mindset for new technologies
  • Cross-cultural collaboration skills
  • Six Sigma/Lean principles knowledge

Key Requirements

  • Bachelor’s degree in Engineering
  • 7+ years of experience in reliability/maintenance engineering
  • 5+ years supporting bulk biologics manufacturing
  • Experience managing globally distributed teams
  • Ability to travel globally

Work Rights

Not specified

Tailored Resume

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