Manufacturing Process Technician (Night Shift) - Multiple Positions

Role Summary

The Manufacturing Process Technician (Night Shift) operates in Amgen North Carolina (ANC) to support 24/7 manufacturing operations. The role completes floor operations in the Services area and is responsible for manufacturing cGMP drug substances. The position follows cGMP practices and maintains a clean, organized workspace.

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

Additional Requirements

• Must be able to work a 12-hour night shift (5:45pm to 6:15am) on a 2-2-3 schedule and support 24/7 operations, including during inclement weather, some holidays, and overtime as required.