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

About the role

Join Amgen's newest and most advanced drug substance manufacturing plant. The Amgen FleXBatch facility combines disposable technologies with traditional stainless-steel equipment for maximum operational flexibility. This facility features best-in-class drug substance manufacturing technologies with embedded Industry 4.0 capabilities and integrates sustainability innovations to reduce carbon and waste as part of Amgen's plan to be carbon-neutral by 2027.

As a Manufacturing Process Technician in Bulk Drug Substance Manufacturing Services, you will support critical 24/7 manufacturing operations on a 12-hour night shift (5:45pm to 6:15am) following a 2-2-3 schedule. This role requires regular attendance, including during inclement weather, holidays, and requested overtime.

Responsibilities

• Complete work in accordance with established cGMP procedures and policies (SOPs, MPs, JHAs, CFR) with strict adherence to safety and compliance.
• Ensure proper gowning and aseptic techniques are always followed.
• Perform hands-on operations including set-up, cleaning, sanitization, and monitoring of equipment in assigned areas.
• Prepare and transfer buffers and media, including weighing and dispensing materials.
• Complete washroom activities: cleaning equipment (small to large scale) used in production.
• Run and monitor critical processes per assigned procedures.
• Perform documentation for assigned functions (e.g., equipment logs, Electronic Batch Records).
• Maintain an organized, clean, and workable space.

Requirements

• High school diploma or GED + 1 year of manufacturing and/or other regulated experience, or an Associate degree.

Qualifications

• Completion of NC BioWorks Certificate Program (preferred).
• Experience in a regulated industry such as biotechnology or pharmaceutical (preferred).
• Basic understanding of GMP principles.
• Strong verbal and written communication skills.
• Proficient in Microsoft Office and knowledge of electronic systems such as EBR/MES, Delta V, and Electronic Quality Systems.
• Ability to perform assignments with a high degree of focus and attention to detail.

Benefits

Amgen offers competitive and comprehensive Total Rewards Plans aligned with local industry standards, supporting your professional and personal growth. The organization fosters an inclusive, collaborative culture with a focus on diversity, ethics, and commitment to advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants 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. Reasonable accommodations for individuals with disabilities are available upon request.