Engineer
Spectraforce Technologies Inc
Job title : Engineer Location : Holly Springs, NC, 27540 Duration : 12 months (Possibility of extension) Working Schedule: Fully 100% Onsite , Dayshift with potential overtime Job Details:
Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience Top 3 Must Have Skill Sets:
Yes Red Flags: Not team player, bad work ethics Interview Process: Phone with hiring manager, followed by virtual interviews with tech transfer team
- In this vital role you will be a part of the Process Development Drug Substance Technology group at 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 manufacturing bioprocessing (upstream and/or downstream) to support plant start-up activities, biologics technology transfer, and process validation
- Support MFG investigation, root cause analysis, CAPA and deviation management
- Support continuous process verification, process monitoring, optimization, complex investigation, and product life cycle management
- Ensure safety and compliance of process development activities
- Provide process on floor process support as required
- Provide support for regulatory filing, inspection, and other CMC activities
Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience Top 3 Must Have Skill Sets:
- Deviation management
- Bioprocessing upstream/downstream
- Greenfield startup
- Apply a fundamental understanding of manufacturing bioprocessing (upstream and/or downstream) to support plant start-up activities, biologics technology transfer, and process validation
- Support MFG investigation, root cause analysis, CAPA and deviation management
- Support continuous process verification, process monitoring, optimization, complex investigation, and product life cycle management
- Ensure safety and compliance of process development activities
- Provide process on floor process support as required
- Provide support for regulatory filing, inspection, and other CMC activities
Yes Red Flags: Not team player, bad work ethics Interview Process: Phone with hiring manager, followed by virtual interviews with tech transfer team
Vacancy posted 3 days ago
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