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

Admincsl

Device standards iso astm ansi usp
Medical device development experience
Test method validation and lifecycle
The role involves developing robust test methods for primary packaging and combination products to support regulatory submission packages

Job Summary

  • The role involves developing robust test methods for primary packaging and combination products to support regulatory submission packages.
  • Candidates must have at least 5 years of related experience in medical device development and testing within the pharmaceutical industry.
  • CSL Behring is a global biotherapeutics leader driven by a promise to save lives through innovative therapies.

Matching Summary

The role involves developing robust test methods for primary packaging and combination products to support regulatory submission packages.

Skills & Requirements

Must-have

  • Device standards ISO ASTM ANSI USP
  • Medical device development experience
  • Test method validation and lifecycle
  • Regulatory submission documentation
  • Equipment specification and qualification

Nice-to-have

  • Applied statistics SAS JMP Minitab
  • Solid modelling software proficiency
  • Optical measurement mechanical testing
  • Collaborative team culture building
  • Prototyping and optical measurement skills

Key Requirements

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

Work Rights

Not specified

Tailored Resume

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