Manufacturing Technician III
3 days ago
We are seeking a highly skilled Manufacturing Technician III to join our team at FUJIFILM Diosynth Biotechnologies. As a key member of our manufacturing team, you will be responsible for operating and maintaining medium to large-scale filtration systems, chromatographic systems, and other equipment to ensure the production of high-quality biopharmaceuticals.
Key Responsibilities- Operate and maintain medium to large-scale filtration systems, including Tangential Flow Filtration (TFF), Hollow Fiber Tangential Flow Filtration (HFTFF), Nanofiltration, and depth filtration.
- Operate and maintain chromatographic systems, including ÄKTA systems.
- Perform pre-packed column operations from 1L to 100L.
- Operate single-use mixing systems, including Pall and GE systems.
- Perform bulk filling and 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, including 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.
- 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.
- GMP experience
- Biotechnology certificate preferred
- Cross training with other identified functional areas
- 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.
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