Downstream Manufacturing Technician III

Position Overview

The Manufacturing Technician III

will work directly with a range of technologies. Dependent upon assignment, the range of technologies exposed to will be :

Company Overview

The work we do at FUJIFILM Biotechnologies Texas has never been more importantand 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 Biotechnologies. We offer a flexible work environment and we're proud to cultivate a culture that will fuel your passion, energy, and drivewhat we call Genki.

Our state-of-the-art biomanufacturing facility is located 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."

Job Description

Essential Functions :

Upstream Unit :

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

Bacterial Fermentation Culture Vessels up to 2000L

Alpha Wasserman Continuous Flow Centrifuge

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 (KTA).

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

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 as assigned.

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 as 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 to include night 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.

Minimum Qualifications :

Bachelor's degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or other related field with one (1) year of relevant manufacturing experience in GMP or regulated industry; OR

Associate degree / Technical certification in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or other related field with two (2) years of relevant experience, one (1) of which should be in manufacturing, GMP or regulated industry; OR

High School / GED with four (4) years of relevant experience, two (2) of which should be in manufacturing, GMP or regulated industry.

Preferred Qualifications :

GMP experience

Biotechnology certificate preferred.

Cross training with other identified functional areas.

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).