Manufacturing Process Tech I

Amgen • Holly Springs, NC

14h • Hybrid

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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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. Manufacturing Process Technician I What you will do Let’s do this. Let’s change the world. In this vital role you will be a Manufacturing Process Technician in the manufacturing organization at Amgen North Carolina (ANC). The initial schedule will be Monday-Friday, 8 hours days, and may include work from home. The schedule will transition to a 12-hour night shift, including every other weekend, as business needs dictate. Mfg. Process Technicians will be completing operations on the floor in the Services area and are responsible for the manufacturing of cGMP (current Good Manufacturing Practices) drug substance. 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. Ensure proper gowning and aseptic techniques are always followed Perform hands-on operation including set-up, cleaning, sanitization, monitoring of equipment and 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

• Associate's degree OR High school/GED + 1 year of manufacturing and/or other regulated work or military experience

Nice To Haves

• Completion of NC BioWork 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

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.
• Ensure proper gowning and aseptic techniques are always followed
• Perform hands-on operation including set-up, cleaning, sanitization, monitoring of equipment and 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

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree