• Hands-on operation of physical and automated equipment to perform microbial fermentations and downstream processing under aseptic conditions at lab and production scale.
• Controlling processes from start-up to shutdown, including media and buffer preparation, equipment sterilization, microbial growth, recovery, filtration, and drying.
• Ensure work is completed in compliance with GMP conditions, with approved SOPs, batch records, controlled documentation and all applicable regulations, guidelines, safety policies and procedures are followed.
• Perform weekly set-up, running, and breakdown of fermentation equipment.
• Participate in cleaning and equipment validation efforts as well as validation documentation within a cGMP facility.
• Actively participating in quality management system, focusing on the batch production records, work instructions and adherence to policies and standard operating procedures at all times.
• Investigate, troubleshoot, create and develop new methods and technologies.
• Author and revise deviations/CAPAs, manufacturing and process equipment documentation, and other technical documentation.
• Work collaboratively with various departments to compile, analyze, and interpret data.
• Assist in management of change associated with production and support equipment, process, and utilities.
• Identify and support continuous improvement initiatives.
• Sanitation and upkeep of all production facilities and maintain a high level of a sterility.
• Must operate equipment and use chemicals in a safe manner.
• Train manufacturing associates as appropriate. Participate in cross-training initiatives.
• Work with data capture systems to store data and metadata about production.
• Use data analysis tools to understand process variations and manage process controls.
• Ensure the accuracy of the warehouse inventory by maintaining accurate bin locations, managing the cycle count process as defined in the ERP system. Ensure counts are accurate and on-time according to plan.
• Maintain a clean, neat, and orderly area.
• Must be able to lift at least 50lbs.
• Must be able to tolerate the noise and odor that results from microbial cell culture.

• Ensure that all production activities are conducted in alignment with safety, quality, and sustainability initiatives.
• Maintain integrity of the production facility and ensure there is no cross-contamination.
• Strong attention to detail in order to produce accurate; precise; and reproducible data.
• Strong analytical; organizational; and time management skills.
• Strong work ethic and prioritization skills.
• Excellent written and oral communication skills.
• Must possess a valid US driver's license.
• Develop and maintain proper bacterial management practices to ensure consistent microbial cell culture that meet quality standards and keep pace with desired production goals.
• All other assigned duties.
• Local travel: Occasional (< 25%)
• Out of state travel: Occasional (< 15%)

• Minimum - High School Diploma or equivalency (GED) and Associates degree.
• Preferred -Bachelor's degree in technical field

• Proficient in MS Office, Excel, and PowerPoint.

• Knowledge of Quality Control and cGMP
• Strong analytical, problem-solving, and attention to detail skills
• Previous aseptic fermentation experience (including centrifugation)
• Previous experience with liquid processing equipment (pumps, valves, mixers, heating, cooling, etc.)

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