This application is for a 6-month student role from July - December 2025. Resume review begins in January 2025. Biogen Engineering at the RTP Pharma site supports two sterile filling lines and an Automated Visual Inspection Machine at the Parenteral Facility and a small-scale filling line, Oligonucleotide Synthesis Manufacturing Area, and an Oral Solid Dose Manufacturing Area in Building 35.  These manufacturing areas are housed within clean spaces which are managed by the Engineering.   Engineering provides technical support and troubleshooting for plant utilities and facilities. Systems supported may include clean utilities (water, air, steam, gasses), HVAC air handlers (clean and office areas), steam systems, waste systems, tower water, and process glycol. Engineering helps with design, installation, modification, troubleshooting and qualification of new and existing equipment, and while providing technical support for the site. Position Description Detailed description of role including but not limited to: This Co-Op will focus on compliance deliverables, managing engineering deviations, CAPAs, effective checks, RARs, AAs, TWAMs and work order management. The role will support both the Facilities and Manufacturing Engineering groups.  In addition, this position will assist with fulfillment of regulatory request, serving as a liaison with the Inspection Management team.  The candidate will work with each department of engineering to understand processes from end to end. They will also interact with each of Biogen’s Computerized Systems to capture information, process flows, and other information. Example projects may include: Metric report creation and maintenance Work Order review and closure Global Change Control tracking Investigation write-ups Creation of Annual Product Reviews 
