Manufacturing Process Technician - Bulk Drug Substance Manufacturing Services - Night Shift
About The Position
Amgen is seeking a Manufacturing Process Technician for its newest and most advanced drug substance manufacturing plant, the Amgen FleX Batch facility. This facility combines disposable technologies with traditional stainless-steel equipment for flexible operations and integrates industry 4.0 capabilities and sustainability innovations to reduce carbon and waste, supporting Amgen's goal of being a carbon-neutral company by 2027. The role supports critical 24/7 manufacturing operations in the Bulk Drug Substance Manufacturing Services area, focusing on the manufacturing of cGMP drug substances.
Requirements
- High school diploma / GED + 1 year of manufacturing and/or other regulated experience
- Associate’s degree
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
- Ability to perform assignments with a high degree of focus/attention to detail.
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.
- 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.
- 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.
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
Associate degree
