OverviewFollow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMOThe 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 GenkiJoin usWe 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 USAbout This RoleThe 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 roleleads projects and handles complex changes while coordinating with other internal and external groups.What You’ll DoSpearheads Automation team through activities, such as code configuration within several process areas and scope workLeads 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 conceptLeads 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 responsibilityLeads medium cross-functional teams through Automation projectsMakes complex decisions across single Automation systemsDesigns Automation systems hardware and software and ensures consistency across platformsServes as on-call support for Automation inquiries and troubleshootingCollaborates with other departments, such as Manufacturing, Maintenance, and ValidationConducts training and presents information to team or other stakeholdersProvides mentorship to other Engineers, as neededOther duties, as assignedBasic RequirementsBachelor’s degree in technical field of study relevant to Automation or Instrumentation & Controls with 12 years of Automation experience ORMaster’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/GMPPersonal ownership and proactive collaboration with external business partners and internal stakeholdersAbility to define Automation standards and shares across siteEffective communication, both written and oralAdvanced strategic thinking skillsAbility to effectively present complex information to othersAbility to remain up to date on regulatory and quality requirements for manufacturing.Ability to train or mentor othersPreferred RequirementsPrior experience and exposure to modelling BPR and eBR recipe components in a Manufacturing Executing SystemWORKING CONDITIONS & PHYSICAL REQUIREMENTSWill work in environment which may necessitate respiratory protection X No YesMay work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. X No YesWill work in environment operating a motor vehicle or Powered Industrial Truck. X No YesAbility to discern audible cues. No X YesAbility to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. X No YesAbility to ascend or descend ladders, scaffolding, ramps, etc. X No YesAbility to stand for prolonged periods of time. No X Yes 30 minutesAbility to sit for prolonged periods of time. No X Yes 240 minutesAbility to conduct activities using repetitive motions that include writs, hands and/or fingers. No X YesAbility to operate machinery and/or power tools. X No YesAbility 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 YesFDBN 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 _.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.Job Locations US-NC-Holly SpringsPosted Date 1 week ago (10/2/2024 3:11 PM)Requisition ID 2024-28033Category Automation EngineeringCompany (Portal Searching) FUJIFILM Diosynth Biotechnologies