API Manufacturing Associate I

Role: Operations technician in API manufacturing at Novo Nordisk's Clayton site, responsible for operating and monitoring automated biopharmaceutical production equipment to meet production targets. Responsibilities include adhering to GMP and cGMP standards, reviewing batch records, troubleshooting equipment issues, participating in qualification and validation activities, maintaining environmental cleanliness, and supporting safety protocols. Requirements: High school diploma; technical, science, or engineering associate's degree preferred; at least 2 years of manufacturing experience in FDA-regulated environments; familiarity with SOPs, safety guidelines, and cGMP manufacturing; basic troubleshooting and mechanical aptitude; competency in computer literacy and documentation. High-value biopharma specifics: sterile API production for injectable oral products, working within a pharmaceutical manufacturing facility with a focus on fermentation, recovery, and purification processes. Collaboration is with shift management and production teams. Work setup: environment may include cold, loud, and confined spaces, with requirements for physical mobility, including lifting, standing for long shifts, and operating motorized equipment. Experience in bioprocessing, biological/chemical knowledge, and familiarity with lockout/tagout systems are preferred.