Associate Manufacturing - Downstream - Night Shift

Amgen • Holly Springs, NC

94d • $73,359 - $85,625

About The Position

Join Amgen's Mission of Serving Patients. At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. 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.

Requirements

• 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.

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.
• Basic knowledge of large-scale biotechnology operations such as purification, cell culture, aseptic processing, etc.
• 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.
• 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]).
• 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.

Benefits

• Competitive and comprehensive Total Rewards Plans aligned with local industry standards.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Chemical Manufacturing
• Education Level: High school or GED