Manufacturing Process Technician, Upstream - Nights - Multiple Positions

Role Summary

Manufacturing Process Technician, Upstream - Nights - Multiple Positions in Amgen’s Upstream manufacturing organization, based in North Carolina. This 24/7 role supports a 12-hour 2-2-3 night shift from 5:45pm to 6:15am and focuses on on-floor operations to manufacture cGMP drug substances in the Services area, with strict adherence to safety and quality standards. The position requires reliable attendance and the ability to work nights, including during inclement weather, some holidays, and overtime as needed.

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 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

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