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 solutionsto 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 2, MES provides support to Drug Substance Manufacturing (DSM). 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 handles complex changes while coordinating with other internal and external groups.
What You’ll Do
- Spearheads Automation team through activities, such as code configuration within several process areas and scope work
- Leads the development of various specification documents (e.g., user requirements specification (URS), functional specification (FS), design qualification (DQ), etc.)
- Drives and coordinates global alignment of our implemented capabilities, maintaining and protecting our global platform concept
- Leads the development of various test protocols and functional testing documents (e.g., installation qualification (IQ), operational qualification (OQ), etc.)
- Plans and implements the technical direction for medium area of responsibility
- Leads medium cross-functional teams through Automation projects
- Makes complex decisions across single Automation systems
- Designs Automation systems hardware and software and ensures consistency across platforms
- 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
- Provides mentorship to other Engineers, as needed
- Other duties, as assigned
Basic Requirements
- Bachelor’s degree in technical field of study relevant to Automation or Instrumentation & Controls with 12 years of Automation experience OR
- Master’s degree in technical field of study relevant to Automation or Instrumentation & Controls with 8+ years of Automation experience.
- Extensive experience with DeltaV MES (Syncade) that includes exposure to understanding behavior code, ET Configuration, EM configuration, DeltaV DCS configuration concepts, SC consumer execution group configuration.
- Proficiency in the fundamental technologies used within DeltaV MES (Syncade), such as SQL Stored Procedures and xPath Matching.
- Previous experience within pharma/GMP
- Personal ownership and proactive collaboration with external business partners and internal stakeholders
- Ability to define Automation standards and shares across site
- Effective communication, both written and oral
- Advanced strategic thinking skills
- Ability to effectively present complex information to others
- Ability to remain up to date on regulatory and quality requirements for manufacturing.
- Ability to train or mentor others
Preferred Requirements
- Prior experience and exposure to modelling BPR and eBR recipe components in a Manufacturing Executing System
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
FDBN is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please email FDBN_PNC@fujifilm.com.
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.
