Principal Engineer, Tech Ops (drug Delivery Systems Testing & Verification)
CSL Behring
Device standards iso astm ansi usp
Test method development and validation
Regulatory submission documentation
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 successful candidate will develop robust test methods for a wide range of drug delivery systems including autoinjectors and on-body devices.
CSL Behring offers a global biotherapeutics environment driven by a mission to save lives through innovative therapies and a strong culture of inclusion.
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
Device standards ISO ASTM ANSI USP
Test method development and validation
Regulatory submission documentation
Equipment qualification and maintenance
Medical device testing experience
Nice-to-have
Applied statistics software SAS JMP Minitab
Solid modelling and prototyping skills
Optical measurement and mechanical testing
Collaborative team culture building
PFS safety systems expertise
Key Requirements
Degree in Engineering, Natural Sciences, or Pharmacy
At least 5 years medical device testing experience
Knowledge of primary container and combination product standards