Manufacturing Process Technician - Bulk Drug Substance Manufacturing Services - Night Shift

Amgen; Holly Springs (NC); On-site; USD 52,000 - 76,000; Full time

Job summary

Amgen North Carolina is seeking a Manufacturing Process Technician for Bulk Drug Substance Manufacturing Services on the night shift. This role supports 24/7 operations and involves a 12-hour schedule from 5:45pm to 6:15am, producing cGMP drug substances.

The technician will perform hands-on operations, including setup, cleaning, sanitization, and equipment monitoring, while adhering to safety, SOPs, and CFR guidelines. Overtime and inclement weather may be required.

Qualifications

• High school diploma or GED plus 1 year of manufacturing or regulated experience.
• Preferred NC BioWorks Certificate.
• Experience in regulated biotech/pharma is a plus.
• Strong communication and documentation skills.
• Familiarity with SOPs, CFRs, and GMP.

Responsibilities

• Completes work in accordance with cGMP procedures with strict adherence to safety.
• Ensure proper gowning and aseptic techniques are always followed.
• Perform hands-on operation including setup, cleaning, sanitization, and equipment monitoring.
• Buffer and Media preparation and transfer.
• Weigh and dispense materials for buffers and medias.
• Complete washroom activities: cleaning equipment and facilities.
• Run and monitor critical processes per procedures.
• Document equipment logs and EBRs.
• Maintain an organized, clean workspace.

Skills

Communication skills

Attention to detail

Team player

Education

High school diploma / GED

NC BioWorks Certificate Program

Tools

DeltaV

EBR/MES

Electronic Quality Systems

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.

Manufacturing Process Technician - Bulk Drug Substance Manufacturing Services - Night Shift

What You Will Do

Let’s do this. Let’s change the world. In this vital role you will be a Mfg. Process Technician 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 5:45pm to 6:15am. Mfg. Process Technician will complete operations on the floor in the Services area and are responsible for the manufacturing of cGMP (current Good Manufacturing Practices) drug substances.

With general direction for routine work and detailed instructions for new assignments, the Mfg. Process Technician 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

• 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 in 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

What We Expect Of You

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.

Basic Qualifications

• High school diploma / GED + 1 year of manufacturing and/or other regulated experience

Or

Preferred Qualifications

• Completion of NC BioWorks 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.

What You Can Expect Of Us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well‑being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.