The Senior Automation Engineer 1 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. This role focuses on leading the Automation scope for delivery of DeltaV logic for CIP & Clean Utilities process areas including Clean-in-Place (CIP), WFI (Water-for-Injection) Generation and Distribution, WPU (Process Water) Generation and Distribution, Clean Steam Generation, and Waste Collection. 

Company Overview

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

The work we do at FUJIFILM Diosynth Biotechnologies 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 FUJIFILM Diosynth Biotechnologies 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.

What You’ll Do

• Spearheads the Automation team through activities, such as code configuration within several process areas

• Leads the development for various specification documents (e.g., user requirements specification (URS), functional specification (FS), design qualification (DQ), etc.)

• Leads the development for various test protocols and functional testing documents (e.g., installation qualification (IQ), operational qualification (OQ), etc.)

• Plans and implements the technical direction for small area of responsibility

• Leads small teams through Automation changes and Tech Transfers

• Makes complex decisions across single Automation systems

• Contributes to Automation system hardware and software designs

• Serves as on-call support for Automation inquiries and troubleshooting

• Collaborates with other departments, such as Manufacturing, Maintenance, and Validation

• Conducts training and presents information to team or other stakeholders

• Other duties, as assigned

Knowledge and Skills

• Personal ownership and proactive collaboration with external business partners and internal stakeholders

• Effective communication, both written and oral

• Advanced problem-solving skills

• Ability to effectively present complex information to others

• Ability to provide feedback to others, including leaders

• Ability to remain up to date on regulatory and quality requirements for manufacturing

Basic Requirements

• Bachelor’s degree in Chemical, Electrical, or Mechanical Engineering or other relevant field with 8 years of Automation, Instrumentation & Controls, or other relevant technical experience

Preferred Requirements

• Master’s degree in technical field of study relevant to Automation or Instrumentation & Controls with 6+ years of Automation experience

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

• Will work in environment which may necessitate respiratory protection X No Yes

• May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. X No Yes

• Will work in environment operating a motor vehicle or Powered Industrial Truck. X No Yes

• Ability to discern audible cues. No X Yes

• Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. X No Yes

• Ability to ascend or descend ladders, scaffolding, ramps, etc. X No Yes

• Ability to stand for prolonged periods of time. No X Yes 30 minutes

• Ability to sit for prolonged periods of time. No X Yes 240 minutes

• Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. No X Yes

• Ability to operate machinery and/or power tools. X No Yes

• Ability to conduct work that includes moving objects up to X pounds. No X Yes If yes, X 10 lbs. 33 lbs.

• Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions. X No Yes