Principal Engineer, Tech Ops – Drug Delivery Systems Testing & Verification
CSL
full-time
Posted on:
Location Type: Office
Location: Waltham • Massachusetts • United States
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Job Level
About the role
- 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.
- Conduct testing with appropriate methods, protocols specifications and equipment (includes product and/or equipment testing), including adhering to test schedules, e.g., stability pulls.
- Establish capabilities and technologies to support product development pipeline.
- Specify, design, and procure specialized test fixtures.
- Author and review rigorous technical documents for inclusion in DHFs, to support regulatory submissions, and to address regulatory inquiry.
- Specify, install, qualify, and maintain test equipment.
- Support the laboratory operation such as sample inventory, equipment qualification, calibration, and maintenance.
- Schedule workload and communicate challenges, scheduling, testing conflicts or other issues to management in timely manner.
- Comply with CSL’s quality assurance requirements and applicable regulatory requirements.
- Actively participate in team efforts to collaboratively deliver development project results.
- Use good judgement and laboratory practice to productively and safely execute testing and test method development in shared laboratory workspace.
Requirements
- Degree in Engineering, Natural Sciences, Pharmacy, or other relevant area.
- At least 5 years of related experience in medical device development and testing within the medical device/pharmaceutical industry.
- Knowledge of device standards, e.g., ISO, ASTM, ANSI, and USP for testing and verification of primary container and combination products.
- Experience with practical applied statistics, SAS/JMP and/or Minitab software, solid modelling software, prototyping, optical measurement, mechanical testing, mechanical aptitude, PFS safety systems, autoinjectors
Benefits
- Health insurance
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
test method developmentproduct testingequipment qualificationcalibrationmechanical testingapplied statisticssolid modellingoptical measurementprototypingvial-to-vial transfer
Soft Skills
communicationteam collaborationproblem-solvingtime managementjudgmentorganizational skills