**Position Overview** The Principal Engineering Manager at Fujifilm Diosynth Biotechnology Texas (FDBT) plays a crucial role under the guidance of the Director of Engineering. This position oversees the Process Engineering team, ensuring effective management of process engineering tasks such as equipment installation, product introduction support, and system assessments. Responsibilities include providing technical expertise and troubleshooting process equipment and utilities like bioreactors, chillers, boilers, among others. Collaboration with various departments like facilities, manufacturing, QA/QC, and contractors is vital for project implementation and maintenance of complex equipment. Key duties involve leading process improvements through Change Control procedures, implementing corrective and preventive actions via the CAPA system, and guiding P&ID development, SOP creation, and equipment commissioning/qualification. The manager also identifies appropriate equipment specifications for future projects. **Company Overview** 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 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 FUJIFILM Diosynth Biotechnologies 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. **Job Description** **_Essential Functions:_** + Manage and provide strategic oversight and effective leadership to the process engineering team. + Direct process engineering staff on implementing process equipment, site utilities, and new technologies. + Provide strategic oversight of engineering activities, troubleshooting support, and technical expertise for process equipment and site utilities. + Facilitate technology and manufacturing program development in support of specific clients and market opportunities. + Lead new product introductions (NPIs) from the infrastructure and process equipment perspective. + Support client, quality, and regulatory audits and inspections. + Lead and manage new equipment/systems installation, including infrastructure, connectivity, and capability assessments. + Implement solutions to engineering problems and/or opportunities and apply technical expertise to develop and present feasible solutions. + Lead and train direct reports in developing change controls for the implementation of new system/equipment installations, process improvements, and site utilities. + Identify new equipment specifications, including type, size, materials, operational conditions, required utilities, and user requirements specifications (URS). + Collaborate with process sciences in developing equipment/systems/process design, controls, requirements, specifications, and drawings. + Liaise with the CAPEX team for the implementation of capital projects. + Direct, lead, and develop engineering staff on process/utilities equipment and new technologies. + Perform all other duties as assigned. **_Required Skills & Abilities:_** + Collaborate effectively with contractors, manufacturing, and quality control. + Communicate efficiently with both internal and external stakeholders. + Support proper testing, validation, and compliance with regulations. + Develop and review SOPs and maintenance procedures. + Ensure compliance with cGMP, FDA, and EHS guidelines. + Maintain a safe work environment and adhere to safety protocols. + Demonstrate leadership and mentorship skills. + Identify and solve engineering problems efficiently. + Manage multiple projects and priorities effectively. + Proficient in project management software and MS Office Suite. + Strong analytical and problem-solving abilities. + Communicate technical information clearly to various audiences. + Self-motivated and adaptable in fast-paced settings. + Pursue continuous improvement and learning. + Knowledge of biomedical/biotechnical equipment and regulatory standards. **_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: + Engage in prolonged periods of sitting, standing, walking, bending, stooping, and stretching. + Utilize hand-eye coordination and manual dexterity to operate portable tools, test instruments, computer keyboard, telephone, calculator, and other office equipment. + Regularly lift and move objects weighing up to 50 pounds. + Climb ladders and stairs of varying heights. + Work under conditions that may be wet or humid. + Provide support during off shifts, weekends, and holidays as needed. + Work in outdoor weather conditions and noisy environments. + Offer 24/7 support for company activities. + Maintain mandatory attendance. **_Minimum Qualifications:_** + Bachelor’s degree in engineeringwith ten (10) to fourteen (14) years of qualified experience in an engineering role in a pharma/biotech manufacturing facility or equivalent, preferably regulated by FDA or any other regulatory agency; OR + Master’s degree in engineering with eight (8) to twelve (12) years of qualified experience in an engineering role in a pharma/biotech manufacturing facility or equivalent, preferably regulated by FDA or any other regulatory agency + A minimum of four (4) or more years of previous leadership experience. **_Preferred Qualifications:_** + Knowledge of bio-processing equipment, clean utilities, and single use equipment + Knowledge of single use technology + Knowledge of quality management software specifically Trackwise. + Knowledge of both Upstream and Downstream processes. + Engineering degree preferably in Mechanical, Chemical, Electrical or Biomedical Engineering. **EEO Information** Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc. **ADA Information** If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBTHR@fujifilm.com or (979) 431-3500). **Job Locations** _US-TX-College Station_ **Posted Date** _1 day ago_ _(5/1/2025 4:24 PM)_ **_Requisition ID_** _2025-34442_ **_Category_** _Engineering_ **_Company (Portal Searching)_** _FUJIFILM Diosynth Biotechnologies_