Manufacturing Process Technician , Upstream - Days - Multiple Positions

Role Summary

Manufacturing Process Technician I, Upstream - Days - Multiple Positions. This role supports Amgen's Upstream manufacturing operations at Amgen North Carolina (ANC) and participates in 24/7 manufacturing. The position works a 12-hour 2-2-3 schedule from 5:45am to 6:15pm and performs floor operations in the Services area to manufacture cGMP drug substances.

Responsibilities

• Completes work in accordance with established cGMP procedures and policies (SOPs, MPs, JHAs, CFR) with strict adherence to safety and compliance.
• Documents accurately tasks performed and/or verified.
• Ensure proper 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.
• Complete washroom activities: cleaning equipment, small to large scale, used in production activities.
• Run and monitor critical processes 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 an 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