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