Combination Product Test Engineer

Job Description Summary

The primary role of the Combination Product Test Engineer is the timely and accurate execution of testing as scoped within individual projects and per client requirements. This includes but is not limited to; sample receipt, prep, storage, and shipping, as well as protocol and report generation, data review and summary. This role utilizes standard and custom laboratory equipment.

Responsibilities

• Conducts timely sample intake, including receipt, proper identification, storage and return shipments as needed
• Conducts testing as assigned utilizing appropriate test methods, protocols specifications and equipment (includes product and/or equipment testing), including adhering to test schedules (e.g. stability pulls, aging pulls).
• Conducts data analysis as per protocol or specifications utilizing variety of data analysis tools (e.g. excel, JMP, MiniTab)
• Communicate challenges, scheduling or testing conflicts and other issues to management in timely manner
• Maintains inventory of lab supplies, including but not limited to; general supplies (e.g. PPE, wipes, cleaners…) and chemicals use for routine testing and/or cleaning
• Conducts routine sample disposition (e.g. return to client, disposal), including coordination of hazardous waste disposal
• Responsible to maintain the lab and storage areas in a clean an organized manner. Includes routine lab cleaning
• Adheres to ZebraSci Quality Systems, including but not limited to; timely identification, and notification of potential Quality Events (e.g. OOS, Deviations, CAPA…) and the subsequent forward processing and investigation of such events
• Follows established Standard Operating Procedures, makes recommendations for edits, enhancements, and/or new procedures
• Reviews and may draft equipment or other lab documents (e.g. SLP, LWIs) under supervision from lab management.
• Reviews test results, including data analysis and draft reports
• Interacts with clients to provide updates and technical overviews as needed under supervision from lab management
• Reviews and may author test methods/protocols/reports under supervision from lab management
• Works and communicates openly, collaboratively, and respectfully with colleagues and staff
• Communicates with clients under the supervision from lab management
• Other activities as assigned

Minimum Requirement

High School Diploma or GED with 2 years of combination of education and experience in laboratory services, medical device, IVD and/or pharmaceutical industry.

Preferred

• Associates degree
• Knowledge of GLP, cGMPs, ISO and ASTM methodologies
• Technical written/oral communication skills with working knowledge of Excel and other data analysis tools