Principal Engineer, Tech Ops (drug Delivery Systems Testing & Verification)
CSL Behring
Multiple Locations
On-site
Develop and validate test methods
Conduct testing with appropriate methods
Specify and procure specialized test fixtures
CSL Behring is seeking a Principal Engineer for their Tech Ops team, focusing on Drug Delivery Systems Testing and Verification. The role involves developing and validating test methods for medical devices, ensuring compliance with regulatory standards, and supporting product development
Job Summary
The Principal Engineer, Tech Ops plays an important role in the medical device and primary packaging development process to deliver specialized testing results from exploratory characterization to design verification results to support regulatory submission packages.
The Testing & Verification Team is involved in device development projects from early stage and is responsible for developing robust methods that can support product development, design verification, and commercial production Quality Control testing and executing testing.
CSL Behring is a global biotherapeutics leader driven by our promise to save lives, focused on serving patients’ needs by using the latest technologies.
Matching Summary
Match Score: 85
CSL Behring is seeking a Principal Engineer for their Tech Ops team, focusing on Drug Delivery Systems Testing and Verification. The role involves developing and validating test methods for medical devices, ensuring compliance with regulatory standards, and supporting product development.
Skills & Requirements
Must-have
Develop and validate test methods
Conduct testing with appropriate methods
Specify and procure specialized test fixtures
Author and review technical documents
Comply with quality assurance requirements
Nice-to-have
Experience with practical applied statistics
Experience with solid modelling software
Experience with prototyping
Experience with autoinjectors
Key Requirements
At least 5 years of related experience
Degree in Engineering, Natural Sciences, Pharmacy, or other relevant area
Knowledge of device standards (ISO, ASTM, ANSI, USP)