Night-Shift Biotech Process Technician

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

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.