Manufacturing Associate, Bulk Drug Substance Upstream - Days
$70,985–$96,038 year
On-siteHolly Springs, North Carolina, United States
Job Summary
Execute hands-on manufacturing operations including setup, monitoring, cleaning, and sanitization of equipment while performing in-process sampling and completing Electronic Batch Records. Support operational readiness, facility startup, and commissioning activities by executing assigned tasks, participating in training, and escalating issues observed during startup execution. Maintain compliance with cGMP procedures, SOPs, and aseptic techniques, ensuring proper gowning and documenting deviations or quality events. Work Monday through Friday from 8am to 5pm during startup phases, transitioning to a 12-hour 2-2-3 schedule from 5:45am to 6:15pm for steady-state operations.
Required Qualifications
- High School/GED + 2 years manufacturing and/or other regulated environment experience
- Associate's Degree + 6 months manufacturing and/or other regulated environment experience
- Bachelor's Degree
- Ability to work assigned 12-hour shift, including during inclement weather, some holidays and requested overtime
- Completion of NC BioWork / BioWorks Certification Program
- Experience in a regulated industry such as biotechnology or pharmaceutical manufacturing
- Basic understanding of cGMP manufacturing environments
- Familiarity with EBR/MES, DeltaV, and electronic quality systems
- Strong verbal and written communication skills
- Demonstrated desire to learn, grow, and develop manufacturing skills
- Ability to work effectively in a team-based manufacturing environment
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