Position Overview

Senior Laboratory Engineering Technical Support Specialist is a senior-level position in the Laboratory Engineering department of FDBT. The primary purpose of this position is to provide day-to-day technical support for the analytical pcs and equipment within Manufacturing, Quality Control, Analytical and Process Development organizations. In addition, this position is a major contributor to supporting new technology and equipment life cycle monitoring.

 

Under minimal supervision, the Senior Laboratory Engineering Tachnical Support Specialist is responsible for the day to day operational, maintenance, calibration, and troubleshooting support for analytical equipment in manufacturing, QC, analytical, and process development. Additional responsibilities include supporting the design, procurement, installation, and start-up of new analytical equipment in accordance with FDBT standards and cGMP regulatory requirements. PC troubleshooting and maintenance along with knowledge of Microsoft Windows Desktop and Server operating systems are required. This position will require support outside of normal business hours.

 

This position requires a sound working knowledge of pharmaceutical analytical/processing equipment and will provide support and ownership of the analytical equipment and systems including but not limited to Ultra Performance Liquid Chromatography (UPLC), High Pressure Liquid Chromatography (HPLC), Liquid Chromatography, Mass Spectrometry, Ultraviolet-Visible Spectroscopy Plate Reader, Densitometry, Cell Counting, and various analytical data collection systems, i.e., Empower, SoftmaxPRO, and Unicorn. The Senior Laboratory Engineering Technical Support Specialist will maintain working knowledge for all such systems allowing for effective technical support. Additionally, understanding of basic networking and a general understanding of Microsoft Active Directory is required an understanding of NTFS file and share security permissions.

Company Overview

The work we do at FUJIFILM Diosynth Biotechnologies Texas has never been more important—and we are looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. 

From developing the next vaccine to advancing cell and gene therapies, we collaborate with industry leaders to tackle complex challenges and deliver meaningful solutions.

If you’re ready to help transform the future of medicine, join FUJIFILM Diosynth Biotechnologies. We offer a flexible work environment and we’re proud to cultivate a culture that will fuel your passion, energy, and drive—what we call Genki. 

Our state-of-the-art biomanufacturing facility is located in in College Station, Texas, which combines a small-town feel with vibrant culture, top-notch schools, and close proximity to big city life. Nestled between major hubs, it’s a dynamic location that blends convenience with innovation.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers

Job Description

Essential Functions:

• Support validation protocols
• Provide hands-on and effective diagnostics/troubleshooting
• Support the design and implementation of sound engineering solutions for mitigating existing operational issues, drive continuous improvement, and introduce new technology in accordance with FDBT standards and cGMP regulatory requirements.
• Provide laboratory engineering support for capital projects concurrently with a dynamic workload based upon site priorities.
• Review technical equipment operating manuals for recommending routine maintenance, calibration, spare parts, configuration, administration, etc.
• Act as a subject matter expert for the development of engineering and validation documents, i.e., User Requirement Specification, Functional Specification, Design Specifications, and Guidelines for new and existing analytical/process equipment systems.
• Assist with training coworkers as well as peers on analytical equipment functionality, troubleshooting, and diagnostic techniques to enhance the overall capability of the organization.
• Develop and revise laboratory engineering
• Capable of understanding and following SOPs.
• Support investigations to properly identify root cause and implement appropriate corrective and preventative actions to prevent reoccurrence.
• Interface and build collaborative partnerships with key site functions including Manufacturing, Analytical and Process Development, Technical Operations, Engineering, and Quality to deliver site goals and objectives.
• Lead simple with minimal guidance and<