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Bioprocess Engineer/Manufacturing Consultant

3 months ago

Bryan, United States Intellectt Inc Full time

Job Summary: We are seeking a highly motivated Bioprocess Engineer/ Manufacturing Consultant to join our team. The ideal candidate will have experience in both upstream and downstream bioprocessing, including handling single-use cell culture vessels, bioreactors, bacterial fermentation, and various filtration and chromatographic systems. This role involves a range of activities from culture monitoring and bioreactor turnaround to aseptic processing and drug product filling. The Bioprocess Engineer will also be responsible for maintaining compliance with cGMP regulations, documenting processes, and ensuring the cleanliness and functionality of the laboratory and manufacturing areas.


Key Responsibilities:

Upstream Operations:

  • Operate and maintain single-use cell culture vessels and bioreactors up to 2000L.
  • Manage bacterial fermentation culture vessels up to 2000L.
  • Monitor cultures, collect samples, and manage the turn-around of bioreactors and fermenters.
  • Perform sterilization and inoculation of bioreactors and fermenters.

Downstream Operations:

  • Operate medium to large-scale filtration systems, including Tangential Flow Filtration (TFF), Hollow Fiber Tangential Flow Filtration (HFTFF), nanofiltration, and depth filtration.
  • Utilize medium to large-scale chromatographic systems, such as ÄKTA.
  • Handle bulk filling, aseptic process simulation, and drug product filling.


Documentation & Compliance:

  • Write and review Standard Operating Procedures (SOPs), buffer formulation records, and batch production records.
  • Ensure all processes and activities are documented and maintained in accordance with cGMP regulations.
  • Assist senior staff in implementing safety and quality assurance programs in compliance with SOPs.
  • Train junior team members on cGMP regulations and standard practices.


Equipment Operation:

  • Operate general production equipment such as autoclaves, glass washers, incubators, analytical scales, and pH/conductivity meters.
  • Perform daily cleaning and sanitization of laboratory and manufacturing areas to maintain a sterile environment.


Qualifications:

  • Associate's or Bachelor’s degree in Biotechnology, Biochemistry, Chemical Engineering, or a related field.
  • 2+ years of experience in a bioprocessing environment, with hands-on experience in both upstream and downstream operations.
  • Strong knowledge of cGMP regulations and aseptic techniques.
  • Proficiency in operating bioprocess equipment and understanding of bioprocessing principles.
  • Excellent organizational, communication, and documentation skills.
  • Ability to work effectively in a team-oriented, fast-paced environment.


Preferred Qualifications:

  • Experience with medium to large-scale bioprocessing systems.
  • Familiarity with specific equipment such as ÄKTA chromatographic systems and Tangential Flow Filtration units.
  • Experience in a pharmaceutical or biopharmaceutical manufacturing setting.