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Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. In this vital role you will be a Mfg. Process Technician in the manufacturing organization at Amgen North Carolina (ANC). The essential position, which supports our critical 24/7 manufacturing operations, works a 12-hour 2-2-3 schedule from 5:45pm to 6:15am. Mfg. Process Technician will complete operations on the floor in the Services area and are responsible for the manufacturing of cGMP (current Good Manufacturing Practices) drug substances.
Job Responsibility:
Complete 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 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
Requirements:
High school diploma / GED + 1 year of manufacturing and/or other regulated experience
Associate’s degree
Nice to have:
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.
What we offer:
Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards