Location: Frederick, MD AstraZeneca is a global, innovation-driven biopharmaceutical business focusing on the commercialization of biologic prescription medicines. This full-time paid internship opportunity is for the summer of 2019. We are seeking candidates who are working towards obtaining a Bachelor's Degree in an Engineering or Science related field. Overview/Objective of the Assignment: To provide an opportunity for an Intern to learn aspects of Equipment/Systems/Process Qualification and Validation within the Biotech industry as well as to facilitate execution of the Periodic Review Program. Responsibilities: Under the direction of a Validation Scientist/Manager, compile cleaning validation data and work with biostatistics group to create / align control limits (warning and action) which will reduce TOC swabbing for revalidation requirements. Deliverables are to create a risk-based technical report to reduce impingment on manufacturing schedule by minimizing requirements of LOTO / TOC swabbing on equipment annually. Using risk-based assessments and FMEA, reduce autoclave cycle annual revalidation requirements to maintain regulatory requirements. Deliverables are to create a FMEA and technical report. Depending upon the Intern’s own goals, there may be opportunities to assist with Validation Protocol generation, field work, and Final Report assembly. Required Skills: -Good documentation practices -Experience working with Microsoft Word, Excel, and PowerPoint -Ability to research independently within AstraZeneca’s Quality, Maintenance and Document Management Systems
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