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Manufacturing Technician Ii

1 month ago

College Station, United States Fujifilm Full time

Overview:
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 III will work directly with a range of technologies. Dependent

upon assignment, the range of technologies exposed to will be:
External US:
**_
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 (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:_**
- Assist with training junior members of the team on basic techniques and/or basic equipment operation.
- Write, review, and revise standard operation procedures, buffer formulation records, and batch production records.
- Identify project specific BOM in SAP.
- Confirm the receipt of materials according to pick list or BOM in SAP.
- Cleaning of materials per applicable procedures prior to entry into the manufacturing facilities.
- Scanning of materials into the production areas in SAP.
- Operate general production equipment such as Autoclaves, Glass washers, Incubators, Analytical Scales, pH/conductivity meters,
- Support our staging coordinators.
- Waste removal.
- 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 GMP regulations.
- Perform all other duties as assigned and/or needed.

**_
Required Skills & Abilities_**
- Excellent oral and written communication skills, interpersonal and organizational
- Proficient with Microsoft Office
- Excellent leadership
- Maintain an effective working relationship with
- Ability to train others to perform to cGMP
- Good self-discipline and attention to
- Flexibility to work outside of normal shift/scheduled hours; as
- Must be able to work alternative shift hours and weekends as
- Excellent math and computer
- Experience working in a cleanroom environment with full clean room gowning and good aseptic
- 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

**_
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
- Hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office
- Potential for exposure to hazardous chemicals, gases, fumes, odors, mists, and dusts, and other hazardous
- Ability to wear personal protective equipment including safety glasses, lab coat, safety shoes and
- Ability to lift/push/pull up to 25 pounds frequently and up to 50 pounds
- Attendance is

**_
Minimum Qualifications:_**
- As

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