Downstream Manufacturing Technician III

The Manufacturing Technician III will work 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 call Genki.

Essential Functions:

• 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
• 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.

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.

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).