Senior Lead Automation Engineer
2 weeks ago
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 Senior Automation Engineer 1 provides support to the Drug Substance Manufacturing (DSM) facility and will lead the Automation activities associated with the site expansion with two additional DSM buildings. This includes implementation of changes to the Automation systems, updating design documents, executing testing, and troubleshooting events. This role leads projects and handle complex changes while coordinating with other internal and external groups.
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
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
- 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
Preferred Requirements
- Master’s degree in technical field of study relevant to Automation or Instrumentation & Controls with 6+ years of Automation experience
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.
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