About the job
The Principal Engineer, Tech Ops (Drug Delivery Systems Testing & Verification) is an exciting opportunity to contribute as an individual in the DDS department at CSL Technical Operations. This job plays a vital role in the medical device and primary packaging development process, delivering specialized testing results that support regulatory submissions. The team thrives on collaboration and innovation, working together to achieve impactful results.
You'll be responsible for
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Developing and validating test methods
Develop, validate, transfer, and life cycle of test methods for vials, transfer devices, e.g., vial-to-vial transfer, syringes, needle-safety devices, autoinjectors, and on-body drug delivery systems.🧪
Conducting testing
Conduct testing with appropriate methods, protocols specifications and equipment (includes product and/or equipment testing), including adhering to test schedules, e.g., stability pulls.⚙️
Establishing capabilities
Establish capabilities and technologies to support product development pipeline.Key criteria
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Device standards knowledge
Understanding of ISO, ASTM, ANSI, and USP standards for testing.View
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Technical documentation skills
Experience authoring and reviewing technical documents for regulatory submissions.View
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Collaborative team experience
Proven ability to influence and promote a culture of continuous improvement.View
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