Manufacturing Technician II

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 Manufacturing Technician II works directly with a range of technologies. Dependent upon assignment, the range of technologies may include any of the following:

External US

Upstream Unit:

Single-Use Cell Culture Vessels/Bioreactors up to 2000L

Bacterial Fermentation Culture Vessels up to 2000L

Alpha Wasserman Continuous Flow Centrifuges

Disposable Magnetic Mixing Bags and Totes

Cell Expansion and Propagation

Banking/Cryopreservation of Cell Lines and Viruses

Hyperstack, Cellstack, and other Adherent Cell Technologies

Plate counting, microscopic examination

Monitor cultures, take samples, turn-around of bioreactor and fermenters, sterilization, and inoculation

Downstream Unit:

Medium to Large-scale filtration systems including Tangential Flow Filtration (TFF), Hollow Fiber Tangential Flow Filtration (HFTFF), Nanofiltration and depth filtration

Medium to Large-scale Chromatographic systems (ÄKTA).

Pre-Packed Columns from 1L to 100L

Single use mixing systems (Pall & GE)

Single Use connectivity types such as GE DAC and Colder AseptiQuik

Bulk filling

Aseptic process simulation and drug product filling

Plate counting, microscopic examination

Monitor cultures, take samples, turn-around of bioreactor and fermenters, sterilization, and inoculation

Buffer Preparation Unit:

Preparation of medium from stock raw materials including the compounding, mixing, testing and filtration for further process needs

Preparation of buffers from stock raw materials including the compounding, mixing, testing and filtration for further process needs

Weighing of raw materials per batch record specifications and assignment of appropriate expiry per procedures

Integrity testing of filters

Essential Functions Include:

Write and review standard operating procedures, buffer formulation records and batch production records.

Assist senior staff in implementing project safety and quality assurance programs in accordance with SOPs.

Maintain the confidentiality of proprietary company information.

Document and maintain activity records according to cGMP regulations and ensure junior team members are trained.

Operate general production equipment such as Autoclaves, Glass washers, Incubators, Analytical Scales, pH/conductivity meters, etc.

Perform daily cleaning and sanitization of the laboratory and manufacturing areas.

Maintain an effective working relationship with others.

Perform all other duties assigned.

Required Skills & Abilities:

Excellent oral and written communication skills, interpersonal and organizational skills.

Proficient with Microsoft Office applications.

Excellent leadership skills.

Ability to train others to perform to cGMP standards.

Good self-discipline and attention to detail.

Must be able to work flexible work hours, and be willing to work outside of normal, scheduled hours; as necessary.

Must be able to work alternative shift hours and weekends as required.

Excellent math and computer skills.

Experience working in a cleanroom environment with full clean room gowning and good aseptic technique.

Must have good planning and time management skills and be willing and able to interface with colleagues in many different roles and functions throughout the manufacturing facilities.

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 standing, some bending, stooping, pushing, pulling, reaching above shoulders and stretching.

Hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment.

Potential for exposure to hazardous chemicals, gases, fumes, odors, mists, and dusts, and other hazardous materials.

Ability to wear personal protective equipment including safety glasses, lab coat, safety shoes and gloves.

Ability to lift/push/pull up to 25 pounds frequently and up to 50 pounds occasionally.

Attendance is mandatory.

Technician II Minimum Qualifications:

Associate’s degree preferably in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or other related field, and 1 year of relevant experience; OR

High School/GED with 2 years relevant experience.

Preferred Qualifications:

Experience in GMP environment

Biotechnology Certificate

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.