Manufacturing Process Technician, Bulk Drug Substance Upstream - Days
About The Position
Join Amgen’s Mission of Serving Patients. Amgen is a global biotechnology company with a mission to serve patients living with serious illnesses. The company has pioneered the biotech industry and focuses on four therapeutic areas: Oncology, Inflammation, General Medicine, and Rare Disease. Amgen is building a new, advanced drug substance manufacturing plant, the Amgen FleX Batch facility, which will combine disposable technologies with traditional stainless-steel equipment for operational flexibility. This facility will feature industry 4.0 capabilities and sustainability innovations to support Amgen's goal of being a carbon-neutral company by 2027. This role is for a Manufacturing Process Technician in the Upstream manufacturing organization at Amgen North Carolina (ANC), supporting critical 24/7 manufacturing operations on a 12-hour 2-2-3 schedule (5:45 am to 6:15 pm). The technician will perform manufacturing of cGMP (current Good Manufacturing Practices) drug substances in the Services area, following general directions for routine work and detailed instructions for new assignments, while adhering to safety and compliance standards.
Requirements
- High school diploma / GED + 1 year of manufacturing and/or other regulated experience
- Associate’s degree
- Ability to perform assignments with a high degree of focus/attention to detail.
Nice To Haves
- Completion of NC BioWorks Certificate Program
- Experience in a regulated industry such as biotechnology or pharmaceutical
- Basic understanding of GMP principles
- Strong verbal and written communication skills
- Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems
Responsibilities
- Completes work in accordance with established cGMP procedures and policies (Standard Operating Procedures [SOPs], Manufacturing Procedures [MPs], Job Hazard Analysis [JHAs], Code of Federal Regulations [CFR]) with strict adherence to safety and compliance.
- Documents accurately tasks performed and/or verified.
- Ensures proper gowning and aseptic techniques are always followed.
- Performs hands-on operation including set-up, cleaning, sanitization, monitoring of equipment in assigned area.
- Buffer and Media preparation and transfer.
- Completes washroom activities: cleaning equipment, small to large scale, used in production activities.
- Runs and monitors critical processes per assigned procedures.
- Performs documentation for assigned function (i.e., equipment logs, EBRs).
- Maintains an organized, clean, and workable space.
Benefits
- Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
Number of Employees
5,001-10,000 employees
