Manufacturing Process Technician - Bulk Drug Substance Manufacturing Services - Day Shift
$54,411–$73,614 year
On-siteHolly Springs, North Carolina, United States
Job Summary
Conduct hands-on operations in the Services area, including set-up, cleaning, sanitization, and monitoring of equipment for cGMP drug substance manufacturing. Perform buffer and media preparation, weigh and dispense materials, and execute washroom activities for cleaning equipment across small to large scales. Complete documentation for assigned functions such as equipment logs and EBRs while maintaining an organized, clean, and workable space. Adhere strictly to established cGMP procedures, SOPs, MPs, JHAs, and CFRs with proper gowning and aseptic techniques. Work a 12-hour 2-2-3 schedule from 5:45am to 6:15pm, including inclement weather, holidays, and overtime to support 24/7 operations.
Required Qualifications
- High school diploma / GED
- 1 year of manufacturing and/or other regulated experience
- Associate's degree
- 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
- 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
- Ability to work assigned 12-hour shift, including during inclement weather, some holidays and requested overtime
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