Associate Manufacturing  – Downstream - Nights (Multiple Positions)

Career Category Manufacturing Job Description HOW MIGHT YOU DEFY IMAGINATION?   You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best   work   alongside other innovative, driven professionals in this meaningful role.   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.     Associate Manufacturing     –   Downstream -   Nights   (Multiple Positions)     Live   What you   will do   Let’s do this! Let’s change the world! In this dynamic role, you will be an Associate 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 5:45 p m to 6:15 a m. Associates will be completing operations on the floor in our   downstream  area and will be responsible for the manufacturing of cGMP (Current Good Manufacturing Practices) drug substances.    With   general   direction, the Associate will support all floor operations in accordance with cGMP practices.   As Amgen relies upon the regular attendance of staff members to meet legitimate business needs, staff must be able to work assigned 12-hour shift, including during inclement weather, some holidays and requested overtime in support of our 24/7 operations.    Responsibilities will include...   Compliance:    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   Assure proper gowning and aseptic techniques are always followed   Process/Equipment/Facilities:    Perform hands-on   downstream bio-tech operations   (Column Chromatography, T angential Flow Filtration   among others )   including set-up, cleaning, sanitization, monitoring of equipment and assigned area   Run and monitor critical process tasks   per   assigned procedures   Perform in-process sampling, operate analytical equipment, and complete process documentation (Electronic Batch Records [EBRs])   Complete washroom activities: cleaning equipment, small to large scale, used in production activities   Initiate and own manufacturing related process deviations   Identify and escalate   issues and concerns regarding   daily routine functions   related to process and tasks ; may engage with team on potential solutions     Perform documentation   for assigned functions (i.e., equipment logs, EBRs)   Collaborate 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   Maintain an organized, clean, and workable space     Win   What we expect   of   you   We are all different, yet we all use our unique contributions to serve patients. The hard-working professional s   we seek   are   team player s   with these qualifications.

High School/GED + 2 years manufacturing   and/or other regulated environment