Senior Production Engineer, Fractionation

CSL Behring

5+ years pharmaceutical manufacturing experience
Aseptic and fractionation processing expertise
Root cause analysis and capa implementation
The role provides technical leadership to ensure optimal asset performance and reliability in alignment with ISO 55000 principles and GMP requirements

Job Summary

  • The role provides technical leadership to ensure optimal asset performance and reliability in alignment with ISO 55000 principles and GMP requirements.
  • Candidates will lead complex troubleshooting, failure investigations, and continuous improvement initiatives for separation, extraction, purification, and filling processes.
  • CSL Behring is a global biotherapeutics leader committed to saving lives through innovative therapies and a culture of inclusion and belonging.

Matching Summary

The role provides technical leadership to ensure optimal asset performance and reliability in alignment with ISO 55000 principles and GMP requirements.

Skills & Requirements

Must-have

  • 5+ years pharmaceutical manufacturing experience
  • Aseptic and fractionation processing expertise
  • Root cause analysis and CAPA implementation
  • GMP and ISO 55000 compliance knowledge
  • SAP CMMS data analysis skills

Nice-to-have

  • Six Sigma or Lean principles knowledge
  • Mentoring junior engineers and technicians
  • Strategic planning and execution capabilities
  • Cross-functional collaboration skills

Key Requirements

  • Bachelor's degree in Engineering
  • Master's degree preferred
  • Proven cGMP environment experience
  • Regulatory inspection support experience

Work Rights

Not specified

Tailored Resume

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