Senior Global Engineering Specialist - Bulk

cslbehring.de

Global sme for bulk biologics manufacturing
Define global maintenance standards
Asset lifecycle management
Serve as global SME for maintenance and reliability of bulk biotech manufacturing areas (upstream and downstream) and develop global maintenance standards for bulk process equipment, utilities, and support systems

Job Summary

  • Serve as global SME for maintenance and reliability of bulk biotech manufacturing areas (upstream and downstream) and develop global maintenance standards for bulk process equipment, utilities, and support systems.
  • Ensure maintenance programs comply with FDA 21 CFR Parts 210/211, EU GMP, and ICH Q7, Q8, Q9, and Q10, and act as an engineering SME during regulatory inspections and internal audits.
  • Partner with Quality, MS&T, Automation, Process Engineering, and Operations teams globally, provide mentoring and technical coaching, and drive knowledge sharing and best practice harmonization across the global network.

Matching Summary

Serve as global SME for maintenance and reliability of bulk biotech manufacturing areas (upstream and downstream) and develop global maintenance standards for bulk process equipment, utilities, and support systems.

Skills & Requirements

Must-have

  • Global SME for bulk biologics manufacturing
  • Define global maintenance standards
  • Asset lifecycle management
  • Troubleshooting and performance optimization
  • 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
  • Executive-level communication skills
  • Six Sigma/Lean principles knowledge

Key Requirements

  • Bachelor’s degree in Engineering
  • 7+ years of experience in reliability 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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