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Job description
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: 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
Basic Qualifications
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
Day to Day Responsibilities: 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
Possible Extension:
Yes
Red Flags:
Not team player, bad work ethics
Interview Process:
Phone with hiring manager, followed by virtual interviews with tech transfer team
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.