R&D Test Engineer

Job Title: R&D Test Engineer Location: Irvine

Duration: Long term

Client: Actalent

Job Description

• Assist in the development of innovative products for drug delivery to patients.
• Define, lead, and execute verification strategies, including creating verification plans, protocols, records, and reports.
• Determine sample size strategy based on scientific rationale conforming to internal and regulatory guidelines.
• Lead and execute test procedures, write protocols supporting engineering and verification testing, analyze data, document in lab notebooks, and present results to cross-functional teams.
• Lead root cause investigations and issue resolutions.
• Define, develop, and validate test methods.
• Recommend improvements in design, processes, and execution of projects or tasks, as well as program maintenance.
• Comply with applicable policies, procedures, regulatory, and safety requirements.
• Review and evaluate design changes for compliance and technical competencies.
• Perform technical duties according to quality and functional standards.
• Conduct tests to determine physical and mechanical characteristics of materials for quality control, process control, or product development.
• Experience with Zwick (or Instron) and flow measurement equipment is preferred. Familiarity with 3D printing, viscometers, climate chambers, etc., is a plus.
• Familiarity with Microsoft Project and Laboratory Information Management System tools such as LinkUS, Requirement/Risk Management tools such as DOORS, or Cockpit is desired.
• Experience with engineering tools such as SolidWorks, Minitab, and Electronic Lab Notebook (ELN) is a plus.
• Demonstrated problem-solving skills and fundamental technical depth are essential.
• Work independently under the guidance of a supervisor or technical lead. Assignments have clear and specified objectives.