Associate Manufacturing; Day Shift

Career Category

Manufacturing

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.

Live

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 initial schedule will be 10 hours shift Mon to Friday 6am to 4pm. The schedule will transition to a 12-hour night shift including every other weekend as business needs dictate. Associates will be completing operations on the floor in our manufacturing services, upstream or downstream area and are responsible for the manufacturing of cGMP (Current Good Manufacturing Practices) drug substance.

Please note; no relocation assistance will be provided for these positions.

With general direction, the Associate will support all floor operations in accordance with cGMP practices.

• 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

• Perform hands‑on operations 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

• Identify and elevate 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

We are all different, yet we all use our unique contributions to serve patients. The hard‑working professionals we seek are team players with these qualifications.

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

Or

• Associate’s Degree + 6 months manufacturing and/or other regulated environment experience

Or

• Bachelor’s Degree

• Completion of NC Bio Work Certificate 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 E /MES, Delta V, and Electronic Quality Systems

• An ability to demonstrate desire and drive to learn and grow their understanding of operations and processes

As we work to develop treatments that take care of others, we also work to…