Manufacturing Process Technician (Day Shift)
Amgen
Full-time
Remote friendly (Holly Springs, NC)
United States
Operations
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Role Summary
Manufacturing Process Technician (Day Shift) at Amgen North Carolina. Responsible for manufacturing cGMP drug substance in the floor Services area, with initial schedule of Monday-Friday days and potential shift transition after startup activities.
Responsibilities
- Perform hands-on operation including set-up, cleaning, sanitization, and monitoring of equipment and assigned area
- Buffer and media preparation and transfer
- Weigh and dispense materials for buffers and medias
- Complete washroom activities: cleaning equipment for production activities
- Run and monitor critical process per assigned procedures
- Document activities (equipment logs, EBRs)
- Maintain an organized, clean, and workable space
- Comply with established cGMP procedures and policies, including SOPs, MPs, JHAs, CFRs; ensure proper gowning and aseptic techniques
Qualifications
- Required: High school diploma / GED plus 1 year of manufacturing and/or other regulated experience
- Or: Associate’s degree
- Preferred: Completion of NC BioWorks Certificate Program
- Preferred: Experience in regulated biotechnology/pharmaceutical environment
Skills
- Basic understanding of GMP principles
- Strong verbal and written communication skills
- Proficient Microsoft Office; familiarity with EBR/MES, Delta V, and Electronic Quality Systems
- Attention to detail and ability to focus on tasks
Education
- High school diploma / GED or Associate’s degree (as listed under Qualifications)
Additional Requirements
- Willingness to work 12-hour shifts from 05:45am to 06:15pm on a 2-2-3 schedule
- Ability to work in a cGMP manufacturing environment