Principal Engineer, Tech Ops (drug Delivery Systems Testing & Verification)
CSL Limited
Device standards iso astm ansi usp
Medical device development experience
Test method validation and transfer
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, validate, and transfer test methods for various drug delivery devices including vials, syringes, and autoinjectors.
CSL Behring is a global biotherapeutics leader driven by a promise to save lives through innovative therapies in immunology, hematology, and other areas.
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
Medical device development experience
Test method validation and transfer
Regulatory submission documentation
Equipment qualification and maintenance
Nice-to-have
Applied statistics SAS JMP Minitab
Solid modelling software proficiency
Optical measurement techniques
Collaborative continuous improvement culture
Prototyping and mechanical aptitude
Key Requirements
Degree in Engineering, Natural Sciences, or Pharmacy
At least 5 years of medical device testing experience
Knowledge of primary container and combination product standards