MSAT Upstream Engineer: Biologics Process Transfer

Avid Bioservices

Tustin (CA)

On-site

USD 95,000 - 119,000

Full time

8 days ago

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Job summary

Avid Bioservices is seeking an Engineer, MSAT Upstream to serve as the main client and internal liaison, ensuring successful transfer and execution of upstream processes in manufacturing. You will collaborate with clients on process status, troubleshoot floor issues, and drive improvements to efficiency and risk reduction.

The role requires 2+ years in biologic upstream manufacturing, strong cGMP knowledge, and hands-on cell culture experience.

Qualifications

Bachelor’s degree in a scientific or engineering discipline required.
2+ years of biologic upstream manufacturing experience.
Strong understanding of cGMPs and ability to resolve deviations on the floor.
Team player with potential to lead projects.
Hands-on cell culture and aseptic technique experience.

Responsibilities

Develop and maintain positive client and internal partnerships.
Communicate process status with clients and troubleshoot on the floor.
Lead process tech transfers, troubleshoot issues, and drive process improvements.
Author Batch Production Records, technical reports, and validation protocols.
Scale-up assessments to translate PD-scale to Manufacturing-scale and assess equipment fit.
Monitor process health and perform risk assessments identifying gaps and improvements.
Provide training to Upstream Operators and assist CAPA investigations.
Investigate root causes and assess impact of process/material/equipment changes.