Downstream Manufacturing Technician II

The Manufacturing Technician II works directly with a range of technologies.

The work we do at FUJIFILM Diosynth Biotechnologies 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 FUJIFILM Diosynth Biotechnologies calls Genki.

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

• 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.

• 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.

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.

• 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.

• Experience in a GMP environment
• Biotechnology Certificate