Principal Engineer, Tech Ops (drug Delivery Systems Testing & Verification)
CSL Behring
Iso astm ansi usp standards knowledge
Medical device development experience
Test method validation and transfer
The role involves developing robust test methods for primary container and combination products to support design verification and commercial production quality control
Job Summary
The role involves developing robust test methods for primary container and combination products to support design verification and commercial production quality control.
Candidates must author and review rigorous technical documents for inclusion in Design History Files (DHF) to support regulatory submissions and inquiries.
CSL Behring is a global biotherapeutics leader committed to saving lives through innovative therapies and a culture of inclusion and belonging.
Matching Summary
The role involves developing robust test methods for primary container and combination products to support design verification and commercial production quality control.
Skills & Requirements
Must-have
ISO ASTM ANSI USP standards knowledge
Medical device development experience
Test method validation and transfer
Regulatory submission documentation
Equipment qualification and maintenance
Nice-to-have
Applied statistics with SAS JMP Minitab
Solid modeling software proficiency
Optical measurement and mechanical testing
PFS safety systems expertise
Collaborative continuous improvement culture
Key Requirements
Degree in Engineering, Natural Sciences, or Pharmacy
At least 5 years medical device testing experience