Senior Manufacturing Process Engineer

Position 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 Sr. Manufacturing Process Engineer works independently, with minimal supervision, and leads projects and colleagues to provide expertise and assistance for the design, development, standardization and maintenance of operational biotechnology utilized in the manufacture of proteins and drug substances. This person will be the subject matter expert on core manufacturing and operational technologies for the manufacturing unit. Operational biotechnologies include: Isolators and their use in cell propagation, Cell Culture/Single Use Technology, Filtration, Chromatography and Final Filtration. Core manufacturing technologies include Weigh and Dispensing and Mixing and Buffer Preparation.

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:

• Responsible for specifying, purchasing, designing, qualifying, and handing over effective manufacturing systems ensuring plant modifications have credible delivery plans.
• Lead continuous improvement of materials to reduce risk and improve efficiencies.
• Responsible for interfacing with internal / external technical experts and peers to maintain a broad knowledge of the technology and regulatory issues that impact the biopharmaceutical business enabling technology options to be identified, evaluated, and compared.
• Lead transfer and scale up of new processes and technologies to the manufacturing plant ensuring requirements for EHS and cGMP compliance.
• Manage the interface between Process Development and Manufacturing to ensure processes and transfers occur seamlessly and provide process engineering expertise to siting exercises placing new processes into the facility.
• Identify and lead change of technology transfer practices to deliver continuous improvements.
• Lead in the training and coaching of project team members to ensure technical and personal objectives are achieved within agreed time frames.
• Ensure best practice operating methods are deployed and assist in resolving operational problems such as deviations, QIPs, CAPAs, etc.
• Take the lead in investigating and resolving events that arise from compliance issues.
• Develop and maintain equipment and unit operation standards and procedures utilizing 4M (Man, Materials, Machinery and Methods) approach.
• All other duties as may be assigned.

 

Required Skills & Abilities:

• Excellent oral and written communication ski