Specialist, Engineering -1

About the role

The Global Vaccine Technology & Engineering (GVTE) Team at the Durham Vaccine Facility in Durham, North Carolina, is seeking candidates for IPT Engineering positions to support manufacturing operations, quality operations, and process automation.

Responsibilities

• Authoring and executing validation protocols
• Authoring Quality Notifications (QNs)
• Providing technical support to manufacturing shop floor for in-process analytics, controls, and troubleshooting
• Analyzing complex processing problems through critical analytical thinking and "on the floor" troubleshooting
• Developing sound scientific justification for planned material and process / equipment changes
• Working with the Operations, Automation, and Quality functions to determine the breadth and scope of investigations to identify the appropriate root cause, implement corrective actions, complete trending analysis, and determine product disposition
• Preparing and/or providing guidance and review for regulatory filings, process descriptions, investigations, and change requests
• Acting as a participant in domestic and international regulatory agency inspections
• Supporting all quality and safety initiatives
• Keeping the supervisor current on the progress of projects, and making improvement recommendations on production procedures
• Supporting on shift support during critical manufacturing runs such as Aseptic Process Simulation, protocol execution, and developmental runs
• Responsible for authoring process change controls and completing tasks to implement Drug Product equipment/process changes

Requirements

• Minimum Requirement: Bachelor of Science Degree in Chemical Engineering, Biochemical Engineering, Bioengineering, or related life science field with a minimum of two (2) years of relevant experience or a Master of Science Degree
• Experience in vaccine or biologics manufacturing within a cGMP environment
• Experience authoring technical documentation (technical investigations, protocols, reports, or change controls) within a cGMP context
• Demonstrated systematic problem-solving skills
• Prominent leader with influence and outstanding communication (written & presentation) skills
• Ability to foster a collaborative work environment

Qualifications

• Education: Bachelor of Science Degree in Chemical Engineering, Biochemical Engineering, Bioengineering, or related life science field with a minimum of two (2) years of relevant experience or a Master of Science Degree
• Experience: Minimum of two (2) years of relevant experience in vaccine or biologics manufacturing within a cGMP environment
• Skills: Demonstrated systematic problem-solving skills, proven leader with influence and outstanding communication (written & presentation) skills, ability to foster a collaborative work environment