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 maximum operational flexibility and integrates industry 4.0 capabilities and sustainability innovations. The role supports critical 24/7 manufacturing operations, working a 12-hour night shift schedule (5:45 PM to 6:15 AM) on a 2-2-3 rotation. The technician will perform operations in the Services area, responsible for manufacturing cGMP drug substances, supporting all floor operations in accordance with cGMP practices, safety, and compliance. Regular attendance, including during inclement weather, some holidays, and requested overtime, is essential for supporting 24/7 operations.
Requirements
- High school diploma / GED + 1 year of manufacturing and/or other regulated experience OR Associate’s degree.
- 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.
Nice To Haves
- Completion of NC BioWorks Certificate Program.
- Experience in a regulated industry such as biotechnology or pharmaceutical.
Responsibilities
- Completes work in accordance with established cGMP procedures and policies (SOPs, MPs, JHAs, 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 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
