Associate Manufacturing – Downstream - Nights (Multiple Positions)

Amgen•Holly Springs, NC

3d•$70,985 - $96,039•Onsite

About The Position

Amgen is building its newest and most advanced drug substance manufacturing plant, the Amgen FleX Batch facility. This facility will combine the latest disposable technologies with traditional stainless-steel equipment for maximum operational flexibility. It will feature best-in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities and integrate sustainability innovations to reduce carbon and waste, supporting Amgen's goal of being a carbon-neutral company by 2027. This role is for an Associate in the manufacturing organization at Amgen North Carolina (ANC), supporting critical 24/7 manufacturing operations.

Requirements

High School/GED + 2 years manufacturing and/or other regulated environment experience
Associate’s Degree + 6 months manufacturing and/or other regulated environment experience
Bachelor’s Degree

Nice To Haves

Completion of NC BioWorks Certification Program
Experience in a regulated industry such as biotechnology or pharmaceutical
Basic understanding and process experience in a cGMP manufacturing facility
Excellent verbal and written communication
Proficient Microsoft Office skills, and knowledge of other electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems
An ability to demonstrate desire and drive to learn and grow their understanding of operations and processes

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.
Assures proper gowning and aseptic techniques are always followed.
Performs hands-on downstream bio-tech operations (Column Chromatography, Tangential Flow Filtration among others) including set-up, cleaning, sanitization, monitoring of equipment and assigned area.
Runs and monitors critical process tasks per assigned procedures.
Performs in-process sampling, operates analytical equipment, and completes process documentation (Electronic Batch Records [EBRs]).
Completes washroom activities: cleaning equipment, small to large scale, used in production activities.
Initiates and owns manufacturing related process deviations.
Identifies and escalates issues and concerns regarding daily routine functions related to process and tasks; may engage with team on potential solutions.
Performs documentation for assigned functions (i.e., equipment logs, EBRs).
Collaborates as part of a cross-functional team (i.e., QA/QC, F&E (Facilities & Engineering), PPIC, Mfg., PD (Process Development), Regulatory, etc.) in completing production activities.
Maintains an organized, clean, and workable space.