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

Role Summary

Manufacturing Process Technician (Day Shift) for Manufacturing Services at Amgen North Carolina. Supports 24/7 manufacturing operations in the Services area, performing on-the-floor operations to manufacture cGMP drug substances on a 12-hour 2-2-3 shift (5:45am–6:15pm). Performs setup, cleaning, sanitization, monitoring of equipment, buffer and media preparation, material weighing and dispensing, and on-floor documentation, all in accordance with cGMP procedures; accurate gowning and aseptic technique are required. Must be able to work assigned shift 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.
• 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

Education

• High school diploma or GED with 1 year manufacturing and/or other regulated experience, or an Associate’s degree.

Additional Requirements

• Ability to work a 12-hour shift (2-2-3 schedule) including inclement weather, some holidays, and overtime to support 24/7 operations.