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 dhf
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 requires developing robust test methods for a wide range of primary packaging and combination products including autoinjectors and on-body drug delivery systems.
CSL Behring is a global biotherapeutics leader driven by a promise to save lives through innovative therapies in immunology, hematology, and other therapeutic 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
Test method development and validation
Regulatory submission documentation DHF
Equipment qualification and maintenance
Medical device testing experience
Nice-to-have
Applied statistics SAS JMP Minitab
Solid modeling software proficiency
Optical measurement techniques
Collaborative continuous improvement culture
Prototyping and mechanical aptitude
Key Requirements
Degree in Engineering or Natural Sciences
At least 5 years medical device testing experience