Principal Engineer, Tech Ops (drug Delivery Systems Testing & Verification)

Century Center

Medical device development experience
Test method validation and verification
Iso astm ansi usp standards knowledge
This role is critical for delivering specialized testing results from exploratory characterization to design verification to support regulatory submission packages

Job Summary

  • This role is critical for delivering specialized testing results from exploratory characterization to design verification to support regulatory submission packages.
  • The position involves developing robust test methods for a wide range of primary packaging and combination products including autoinjectors and on-body drug delivery systems.
  • CSL Behring operates one of the world's largest plasma collection networks and employs over 32,000 people globally to deliver lifesaving therapies.

Matching Summary

This role is critical for delivering specialized testing results from exploratory characterization to design verification to support regulatory submission packages.

Skills & Requirements

Must-have

  • Medical device development experience
  • Test method validation and verification
  • ISO ASTM ANSI USP standards knowledge
  • Regulatory submission documentation
  • Equipment qualification and maintenance

Nice-to-have

  • Practical applied statistics expertise
  • SAS JMP Minitab software proficiency
  • Solid modeling software skills
  • Optical measurement techniques
  • Collaborative continuous improvement culture

Key Requirements

  • Degree in Engineering Natural Sciences Pharmacy or relevant area
  • At least 5 years of related medical device testing experience
  • Knowledge of device standards ISO ASTM ANSI USP

Work Rights

Not specified

Tailored Resume

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