North Carolina Biotechnology Center (NCBiotech) - Biopharmaceutical Manufacturing SkillBridge Program - Process Technician

The service member will receive focused training to become a skilled technician by gaining industry knowledge in areas such as Fermentation, Purification, Media Preparation, Buffer Preparation, or other assigned processes in the production area. The Track I Intern will gain significant knowledge in aspects of Operations Support processes utilizing current Good Manufacturing Practices (cGMP) performing all aspects of GMP facility sanitization within the manufacturing areas. Internship report hours/days will be determined based on assignment not to exceed 40 internship hours per week.

As a Process Technician/Manufacturing Associate you will be completing operations on the manufacturing floor helping to create whatever product the assigned organization produces. The initial schedule will be Monday-Friday, 8-hour days, and may include work from home. The schedule will transition to a 12-hour night shift as business needs dictate. Process Technicians/Manufacturing Associates will support all floor operations in accordance with cGMP practices (Current Good Manufacturing Practices). Responsibilities will include compliance: Completes work in accordance with established cGMP procedures and policies (Standard Operating Procedures [SOPs], Manufacturing Procedures [MPs], Job Hazard Analysis [JHAs], Code of Federal Regulations [CFR]) with strict adherence to safety and compliance while assuring proper gowning and aseptic techniques are always followed.Process/Equipment/Facilities:Perform hands-on operations including set-up, cleaning, sanitization, monitoring of equipment and assigned area. Run and monitor critical process tasks per assigned procedures. Perform in-process sampling, operate analytical equipment, and complete process documentation (such as Electronic Batch Records [EBRs]). Execute and complete washroom activities: cleaning equipment, small to large scale, used in production activities. Identify and escalate issues and concerns regarding daily routine functions related to process and tasks; may engage with team on potential solutions. Perform documentation for assigned functions (i.e., equipment logs, EBRs). Collaborate as part of a cross-functional team (i.e., QA/QC, F&E (Facilities & Engineering), PPIC, Mfg., PD (Process Development), Regulatory, etc.) in completing production activities.

• Preferred: BioWork Certificate or associate’s degree or at least 2.5 years of pharmaceutical manufacturing experience • Required: High School Diploma (or equivalent) plus at least 3 years of military service