Sr Automation Engineer 1, DPFG

Position Overview

The Senior Automation Engineer 1, MES provides support to the Drug Product Finished Goods Manufacturing (DPFG) 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 leads projects and handle complex changes while coordinating with other internal and external groups.

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.

 

Job Description

What You’ll Do

• Leads the design and integration of OEM equipment for formulation, filling, and automated inspection processes into the site infrastructure.
• Manages ongoing and new automation projects, ensuring delivery within budget, timelines, and quality standards while aligning with company objectives.
• Ensures integration and synchronization of MES systems with production equipment and infrastructure.
• Oversees automation testing during FAT, commissioning, and site validation activities.
• Leads change control processes and ensure compliance with Good Manufacturing Practices (GMP).
• Develops and mentor’s junior and senior engineers, fostering a culture of technical excellence and continuous learning.
• Stays current with industry trends and advancements, recommending improvements to maintain cutting-edge automation capabilities.
• Leads the development for various specification documents (e.g., user requirements specification (URS), functional specification (FS), design qualification (DQ), etc.)
• Plans and implements the technical direction for area of responsibility
• Leads small teams through Automation changes and Tech Transfers including schedule development and project management
• Makes complex decisions across single Automation systems
• 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
• Performs 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 technical field of study relevant to Automation or Instrumentation & Controls with 8 years of Automation experience OR
• Master’s degree in technical field of study relevant to Automation or Instrumentation & Controls with 6+ years of Automation experience.
• Experience with MES systems and OEM equipment integration.
• Knowledge of computer networking, switches, and communication troubleshooting

Preferred Requirements

• Proficiency in the fundamental technologies used within PAS-X
• Expertise with Siemens PLC/HMI programming, AVEVA (Wonderware) SCADA and AVEVA PI Historian
• Previous experience within pharma/GMP experience