**Overview** **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 create 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 FDB call Genki.** College Station, Texas may be a small, university town, but the lively cultural scene and local amenities make it a great place for families as well as those who want the ease of small-town life and the convenience of living close to the vibrant pulse of big cities. Eighty-seven percent of Texas' population lives within a 180-mile radius, so we are in the center of it all in Texas. And our site is nestled in the hub of innovation, representing a source of pride for the area. **_Summary_** **:** The Principal Automation Engineer provides technical support and accountability for the execution of capital projects and business operations that are critical to the success of our business. Takes bold steps to modernize technical operations so we can deliver medicines more quickly, efficiently and reliably. The Principal Automation Engineer will participate in thedevelopment, installation, operation, maintenance, and repair of all FUJIFILM Diosynth Biotechnologies Texas automation systems to meet organizational goals and objectives.This position will also work closely with other operators, calibration technicians and engineers to maintain complex systems, train other Engineers and Technicians in the Automation area. **External US** **_Essential Functions:_** + Support validation as Subject Matter Expert to ensure that appropriate regulations (e.g. 21 CFR Part 11 and cGMP) are addressed in validation in a development phase and level. + Lead complex projects with minimal guidance and supervision. + Interfaces with IT to ensure GMP compliant integration with Corporate IT infrastructure. + Prepare, assist, and participate in system, specification development, and design. + Provide support on a daily basis on BMS, SCADA, DCS, GMP controls, Utility Controls, Process Equipment PLC’s, Utilities Equipment PLC’s and GMP data archiving and retrieval. + Maintain FS, SDDS and HDDS documents for automation systems. + Develop and maintain Automation SOPs, forms, documentation and files. + Perform Engineering Test Plans for Automation. + Execute Software Test Specification. + Maintain backups of automation code. + Provide engineering and technical review of new equipment purchases, including Request for Quote Bid Packages, design review, FAT and SAT. + Provide technical review of SOP and Batch Records as necessary. + Create new and update existing maintenance procedures and spare part identification for automation systems. + Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable laws, regulation and industry codes. + Knowledge of cGMP practices utilized in bulk drug and vaccine manufacturing environment. + Plan, design and implementation of Backup and Disaster Recovery strategies. + Implementation of Data Integrity solution using industry guidelines and requirements. + Performs other duties as assigned. **_Required Skills & Abilities:_** + Experience with Process Control System, SCADA design, implementation and operation required. + Develop and provide trainings to operational personnel as needed as Automation SME. + Develop new code for continuous control and batch control required. + Experience with critical utility and non-GMP utility systems a plus. + BMS, SCADA and DCS design, commissioning and validation in GMP facility required. + Familiarity with GAMP and other approaches to System Development Life Cycles (SDLC), CAPA. + Computer knowledge of 21 CFR Part 11. + Understand automation protocols like: HART, Foundation Fieldbus, Traditional I/O, Profibus, Ethernet I/P, OPC and Modbus TCP/IP. + Experience with DCS, SCADA and BMS systems such as DeltaV, Factory Talk View, APOGEE, etc. preferred. + Reliable, self-motivated individual with positive attitude; team-oriented with the ability to work with staff covering a variety of roles. + Ability to effectively manage time and prioritize tasks to meet tight timelines and shifting priorities. + Strong written, verbal and interpersonal communications skills and a strong attention to detail. Must be able to develop, draft and correct preventative maintenance procedures for technical equipment. + Must be able to work effectively and efficiently with minimal supervision in a schedule-driven, ever-changing work environment. + Working knowledge of MS Office products (Word, Excel, Outlook, and Power Point). + Desire to work in fast-paced, state of the art, alternately research and customized manufacturing facility. **_Working Conditions & Physical Requirements:_** The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to: + Experience prolonged sitting, standing, bending, stooping, climbing and stretching. + Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required. + The ability to regularly lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds. + Be exposed to noisy environments. **_Qualifications:_** + S. in Chemical, Electrical or Mechanical Engineering. + Subject matter expertise in process control, large-scale pharmaceutical/biologics manufacturing process and engineering fundamentals in drug substance. + At least 12 years of relevant automation engineering experience in the biotechnology /pharmaceutical industry. **Join us! FDB is advancing tomorrow’s medicine, impassioning employees to chase the impossible and continually expand their potential. We are a company of emboldened goal seekers – driven by an innate desire to better ourselves, our families, our workplace, our company, our community, and the world at large.** We are an equal opportunity and affirmative action employer.  All qualified applicants will receive consideration without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, disability, protected veteran status or any other characteristic protected by applicable federal, state, or local law. If an accommodation to the application process is needed, please email FDBTHR@fujifilm.com or call 979-431-3500. _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-TX-College Station_ **Posted Date** _2 days ago_ _(12/12/2024 3:01 PM)_ **_Requisition ID_** _2024-32827_ **_Category_** _Engineering_ **_Company (Portal Searching)_** _FUJIFILM Diosynth Biotechnologies_