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 Automation Engineer 2 will provide support to the Drug Substance Manufacturing (DSM) facility. This includes implementation of changes to the Automation systems, updating design documents, executing testing, troubleshooting events, and being a part of Automation on-call support.

During the project phase, the main responsibility as a Computer System Validation (CSV) Automation Engineer 2 will be to prepare validation documentation and contribute to the qualification of Drug Substance Manufacturing (DSM) GxP Automation Computerized Systems. This role will partner with other departments locally and other sites to align strategies and procedures. Once operational, this role will be responsible for ensuring that all DSM GxP Automation Computerized Systems are maintained in a validated state throughout their lifecycle with a focus on consistent policy administration. Additionally, there will be involvement in facilitating improvement initiatives and supporting regulatory agency and third-party inspections.

What You’ll Do

• Performs Automation activities, such as code configuration, document development, and test execution within several process areas
• Delivers accurate and on-time Automation work
• Creates standard code utilizing medium complexity control strategies
• Collaborates with senior Engineers to develop (generate, review, maintain) various specification documents (e.g., user requirements specification (URS), functional specification (FS), design qualification (DQ), etc.)
• Collaborates with senior Engineers to develop (generate, review, maintain) various test protocols and functional testing documents (e.g., installation qualification (IQ), operational qualification (OQ), etc.)
• Serves as on-call support for Automation inquiries and troubleshooting
• Collaborates with other departments, such as Manufacturing, Maintenance, and Validation
• Other duties, as assigned

Knowledge and Skills

• Effective communication, both written and oral
• Strong problem-solving skills
• Ability to effectively present information to others
• Ability to interpret and demonstrate knowledge of an Automation subject area to internal partner

Basic Requirements

• Bachelor’s degree in Chemical, Electrical, or Mechanical Engineering or other relevant field
• 2 years of Automation, Instrumentation & Controls, or other relevant technical experience

Preferred Requirements

• 3+ years of Automation experience