Downstream Manufacturing Technician II (Night Shift)

FUJIFILM Diosynth Biotechnologies • College Station, TX

148d

About The Position

The Manufacturing Technician II work directly with a range of technologies. This position involves working in both downstream and upstream units, handling various biomanufacturing processes and equipment. Responsibilities include operating filtration systems, chromatographic systems, and bioreactors, as well as preparing buffers and media. The role requires adherence to cGMP regulations and involves writing and reviewing standard operating procedures, maintaining confidentiality, and ensuring quality assurance in manufacturing processes.

Requirements

• Associate's degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering, or related field with 1 year of relevant experience; OR High School/GED with 2 years of relevant experience.
• Excellent oral and written communication skills.
• Proficient with Microsoft Office applications.
• Experience working in a cleanroom environment with good aseptic technique.
• Ability to work flexible hours, including alternative shifts and weekends.
• Good planning and time management skills.

Nice To Haves

• Experience in a GMP environment.
• Biotechnology Certificate.

Responsibilities

• Operate medium to large-scale filtration systems including Tangential Flow Filtration (TFF) and Hollow Fiber Tangential Flow Filtration (HFTFF).
• Handle medium to large-scale chromatographic systems (ÄKTA).
• Prepare and manage pre-packed columns from 1L to 100L.
• Utilize single-use mixing systems and connectivity types.
• Conduct bulk filling and aseptic process simulation.
• Perform plate counting and microscopic examination.
• Monitor cultures, take samples, and manage bioreactor and fermenter operations.
• Prepare buffers and media from stock raw materials.
• Write and review standard operating procedures and batch production records.
• Assist in implementing project safety and quality assurance programs.
• Document and maintain activity records according to cGMP regulations.
• Train junior team members on cGMP standards.
• Perform daily cleaning and sanitization of laboratory and manufacturing areas.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Merchant Wholesalers, Durable Goods
• Education Level: Associate degree
• Number of Employees: 1,001-5,000 employees