Job Title Quality Engineer Intern Requisition JR000014799 Quality Engineer Intern (Open) Location Raleigh, NC Additional Locations Job Description Summary The Quality Engineer Intern would gain an understanding of day-to-day operation of a 24/7 Active Pharmaceutical Ingredient manufacturing facility, including the supporting Quality Control laboratory. The Quality Engineer Intern will support the Quality Control team and the Quality Systems team, gaining an understanding in analytical method validations and quality risk assessments for pharmaceutical manufacturing. Projects the intern will participate in or lead are as follows: o Perform sample analysis and/or author protocols in conjunction with multiple analytical method verifications/validations. o Write and execute experimental plans for solution stability studies, including statistical analysis of results. o Develop a Risk Management system for documenting, storing, and logging risk assessments for various quality systems and legacy documents. o Create risk assessments and templates. Aid in training others on how to compose risk assessments by creating best practices. Job Description Essential Functions + Complete one or more special projects intended to be led by candidate and completed within the summer term. + Practice basic lab-bench skills (pipettes, balances, titration, pH, etc.) as well as hands-on opportunities with instrumentation (FTIR, UV/Vis, Chromatography, etc.). Perform and/or coordinate qualitative tests and quantitative assays using techniques on equipment varying from standard analytical equipment to modern automated instrumentation. + Work with various site departments (Quality, Manufacturing, Warehouse/Receiving, etc.) to document, create, and train others on risk assessments. + Independently interpret and evaluate data in terms of accuracy and precision in relation to established expectations. + Engage in safety discussions and follow laboratory and plant safety requirements. + Engage with Quality Control and Quality Systems team members on group goals and delivers on individual responsibilities. + Demonstrated ability to perform duties with a sense of urgency and delivers results in order of business impacting priorities. Minimum Requirements Education / Experience / Skills: + College Degree BS/AS in Engineering, Chemistry or science-related field, either in-progress or completed. + 0-1 years of experience in a science-related field. Knowledge of lab bench skills, lab instrumentation, or pharmaceutical manufacturing/testing is a plus. Organizational Relationship/Scope: + The intern will report to the Quality Control manager, but will be indirectly managed by Quality Systems Manager on certain projects. Other senior staff members may advise on a task-by-task basis. Frequent interaction with other site department personnel including site Quality Assurance, Manufacturing, Warehouse/Receiving and corporate partners. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. At Mallinckrodt, we know that we contribute to something that matters because we make quality products that impact patient lives. Our dynamic work environment provides unique experiences for employees to grow and develop. Invest in your own career with Mallinckrodt and let’s do something dynamic together. Mallinckrodt provides equal employment opportunities to applicants and employees without regard to race; color; gender; gender identity; sexual orientation; religions practices and observances; national origin; pregnancy, childbirth, or related medical conditions; protected veteran status; disability; or any other category protected by law. Additional information on Mallinckrodt’s hiring practices may be found by clicking (https://secure.compliance360.com/ext/ESLKi3LFkqY=)