Principal Engineer, Tech Ops (Drug Delivery Systems Testing & Verification)

CSL Plasma•Waltham, MA

1d•Onsite

About The Position

The Principal Engineer, Tech Ops (Drug Delivery Systems Testing & Verification) is an individual contributor role in the DDS department within CSL Technical Operations, reporting to the Director of Testing & Verification. This role is crucial in the medical device and primary packaging development process, focusing on delivering specialized testing results from exploratory characterization to design verification to support regulatory submission packages. The Testing & Verification Team is involved in device development projects from early stages, responsible for developing robust methods to support product development, design verification, and commercial production Quality Control testing, as well as executing these tests.

Requirements

Knowledge of device standards, e.g., ISO, ASTM, ANSI, and USP for testing and verification of primary container and combination products.
Excellent written and verbal communication skills including face to face and with professional media such video conference, telephone, email
Experience working in a collaborative team environment; demonstrated skill influencing/building/promoting a productive culture of continuous improvement.
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.

Nice To Haves

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

Responsibilities

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.