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Engineer

Company:
Calsoft Labs
Location:
Holly Springs, NC, 27540
Posted:
April 16, 2026
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Description:

Note:

Fully Onsite

Working Schedule: Dayshift with potential overtime

Job Details: In this vital role you will be a part of the Process Development Drug Substance Technology group at Client s FleX Batch Biologics Manufacturing Facility. This role will be immersed in all aspects of operations in a commercial bulk drug substance facility, which includes collaborating with other drug substance teams across our network.

" Apply a fundamental understanding of Downstream bioprocessing to support biologics technology transfer, process validation, plant start-up, MFG troubleshooting and investigations

" Support continuous process verification, process monitoring, optimization, complex investigation, and product life cycle management

" Ensure safety and compliance of process development activities

" Provide person-in-plant on floor process support as required

" Provide support for regulatory filing, inspection, and other CMC activities

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