Biogen
Co-op, Pharma Quality Engineering
Biogen, Durham, North Carolina, United States, 27703
Job DescriptionThis application is for a 6-month student role from January - June 2025. Resume review begins in October 2024.The RTP Pharma site supports two sterile filling lines in the Parenteral Fill (PF) facility, a small-scale filling line, an Oligonucleotide Synthesis Manufacturing (OSM) Area, and an Oral Solid Dose (OSD) Manufacturing Area. As a Co-Op in Quality Engineering, the successful candidate will help ensure that Quality systems supporting facility, equipment, automation, and utilities remain in compliance with Biogen and industry cGMP standards.These activities would include support of facility and equipment controls and release from planned shutdowns of the various manufacturing areas, as well as general facility and equipment oversight (e.g., pest control program and calibration/Remedial Action Report program, respectively).The successful candidate will assist the Quality Engineering team with process improvements to site-specific procedures and global programs. Specifically, the Co-Op will collaborate with Manufacturing Operations and Site Services to harmonize manufacturing area shutdown practices across PF, OSM, and OSD, which will result in revision to two site-specific procedures. The Co-Op will also collaborate with Site Services and other Biogen locations to make improvements to pest control reports and trending, therein revising the procedure defining the global pest control program. Lastly, the Co-Op will collaborate with Instrumentation and Controls, as well as other Biogen locations, to improve upon Remedial Action Report (RAR) trending and revising the procedure that defines the global RAR program.Example projects may include:Shutdown Procedure AlignmentPest Control Program ChangesRemedial Action Report Program ChangesOther projects, as assignedQualifications:Knowledgeable in Microsoft Office / SharePoint is a plusAbility to hit deadlines and understand processes from start to finishGreat communication skillsTo participate in the Biogen Internship Program, students must meet the following eligibility criteria:Legal authorization to work in the U.S.At least 18 years of age prior to the scheduled start dateBe currently enrolled in an accredited community college, college or universityEducationRising Sophomore or above & enrolled in an Engineering or Scientific Undergraduate or Master's degree programLocationThis position is on-site in Research Triangle Park, NC.
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