Engineer 2 / Scientist 2, Process Science Lab

Overview

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

The work we do at FDB has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki

 

Join us 

We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.

 

The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.

External US

About This Role

The Engineer 2, Lab will provide technology transfer support and technical oversight during manufacturing operations.

 

What You’ll Do

• Leads and supports technology transfer (TT) sub-team activities by conducting lab and pilot plant experiments
• Collaborates and leads execution of sampling protocols, as directed
• Participates in writing and reviewing master batch records (MBRs) and standard operating procedures (SOPs)
• Supports training of manufacturing staff
• Supports training members of the process sciences group on the use of equipment in the lab and pilot plant areas
• Analyzes and summarizes lab data for clients
• Writes process performance qualification (PPQ) protocols and reports
• Supports and leads TT within unit operation, as directed
• Interprets and communicates results to the TT team
• Provides technical support for troubleshooting, process assessments, and execution of root cause analysis (RCA) and corrective and preventive action (CAPA) in response to process deviations
• Writes reports and aids in closing out deviations
• Provides process training and consultation on topics related to manufacturing and process
• Provides input to technical risk assessments for new manufacturing processes
• Contributes to the management of manufacturing data (i.e., databasing) and the statistical analysis aimed at process monitoring and resolution of investigations
• Collaborates with the manufacturing department to support commercial and clinical manufacturing campaigns, including on-floor support
• Supports continuous improvement projects, in partnership with manufacturing when applicable, to improve manufacturability, reliability, yield and cost
• Manages lab equipment
• Collaborates with colleagues to develop lab scale protocols
• Executes and oversees sampling plans for lab runs
• Serves as on-call for lab issues and concerns
• Other duties, as assigned

Knowledge and Skills

• Ability to develop effective working relationships internally and externally
• Effective communication, both written and oral
• Ability to provide feedback to others, including leaders
• Strong problem-solving skills
• Project management skills
• Ability to effectively present information to others
• Ability to provide standard professional advice and to create reports and analyses for revie

Basic Requirements

• Associate degree in Engineering, Life Science or Chemical Engineering with 4 years of related work experience (e.g., manufacturing); or
• Bachelor’s degree in Engineering, Life Science or Chemical Engineering with 2 years of related work experience (e.g., manufacturing); or
• Master’s degree with no prior experience
• Experience using quality systems (e.g., deviation management, change control, CAPA, document management system)

Preferred Requirements

• Experience working in a Good Manufacturing Practices (GMP) environment

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

Will work in environment which may necessitate respiratory protection X No YesMay work in Mechanical/Production spaces that may require hea