Manufacturing Process Technician (Night Shift) - Manufacturing Services - Multiple Positions

Role Summary

Manufacturing Process Technician (Night Shift) in Manufacturing Services, Amgen North Carolina. Supports 24/7 manufacturing operations on a 12-hour 2-2-3 schedule (5:45pm–6:15am). Performs floor operations in the Services area and is responsible for the manufacturing of cGMP drug substances under general direction for routine work and detailed instructions for new assignments.

Responsibilities

• Completes work in accordance with established cGMP procedures and policies (SOPs, MPs, JHAs, CFR) with strict adherence to safety and compliance.
• Ensure accurate gowning and aseptic techniques are always followed
• Perform hands-on operation including set-up, cleaning, sanitization, monitoring of equipment in assigned area
• Buffer and Media preparation and transfer
• Weigh and dispense of materials to be used in the preparation of Buffers and Medias
• Complete washroom activities: cleaning equipment, small to large scale, use in production activities
• Run and monitor critical process per assigned procedures
• Perform documentation for assigned function (i.e., equipment logs, EBRs)
• Maintain an organized, clean, and workable space

Qualifications

• Required: High school diploma / GED + 1 year of manufacturing and/or other regulated experience OR Associate’s degree
• Preferred: Completion of NC BioWorks Certificate Program
• Preferred: Experience in a regulated industry such as biotechnology or pharmaceutical
• Preferred: Basic understanding of GMP principles
• Preferred: Strong verbal and written communication skills
• Preferred: Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems
• Preferred: Ability to perform assignments with a high degree of focus/attention to detail

Skills

• Verbal and written communication skills
• Proficient in Microsoft Office; knowledge of EBR/MES, Delta V, and Electronic Quality Systems
• Attention to detail

Education

• High school diploma or GED
• Associate’s degree
• NC BioWorks Certificate Program