Manufacturing Associate 3 (Upstream)- Night Shift (2-2-3)
On-siteHolly Springs, North Carolina, United States
Job Summary
Contribute to project-phase operational readiness for bulk drug substance manufacturing by supporting procedure review, creation, and process transfer. Lead and document manufacturing processing steps while performing in-process testing and executing validation protocols according to cGMP standards. Provide testing and commissioning support for equipment systems, with up to 25% travel required during the project phase. Maintain required training and manage materials through cycle counts in a 24/7 cGMP environment. Work assigned shifts including weekends and potential nights, performing other duties as assigned. This role supports the upcoming North America's largest end-to-end CDMO biopharmaceutical manufacturing facility in Holly Springs, North Carolina.
Required Qualifications
- High School Diploma or GED
- 4+ years of related manufacturing experience
- Associate's degree
- 2+ years of related experience in a cGMP manufacturing environment
- BA/BS
- Life Sciences or Engineering
- Equivalent military training/experience
- Qualified experience on a unit operation (e.g., DPFG Filler or Cell Culture—Seed Train)
- Knowledge of production equipment operation within assigned unit operations
- Basic understanding of manufacturing run cadence and order of shift activities
- Knowledge of cGMPs, safety, and operational procedures
- Ability to assist in troubleshooting
- Strong verbal and written communication skills
- Ability to work effectively in a team environment
- Travel up to 0–25% (domestic or international)
- Work assigned shifts in a 24/7 operation, including weekends and potential nights
Desired Qualifications
- BioWorks or BTEC Capstone cGMP coursework
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