Engineer

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