• Prepare production media and buffers, sterilize equipment, operate bioreactors, and perform seed scale-up from lab pilot to production scale.
• Ensure work is completed in compliance with approved SOPs, batch records, controlled documentation and all applicable regulations, guidelines, safety policies and procedures are followed; Must understand and comply with OSHA safety requirements.
• Ensure that all equipment is operating as intended and properly maintenance.
• Research equipment and process modifications for better efficiency.
• Perform weekly set-up, running, and breakdown of bioreactors, including work in off hours.
• Maintain and repair the fermentation systems and the supporting infrastructure as needed.
• Participate in cleaning and equipment validation efforts as well as validation documentation within a cGMP facility.
• Investigate, troubleshoot, and create and develop new methods and technologies.
• Author, review, and revise deviations/CAPAs, manufacturing and process equipment documentation, and other technical documentation, as necessary.
• Perform or assist third parties in performing standard preventative maintenance programs.
• Work collaboratively with various departments to compile, analyze, and interpret data.
• Assist in change controls associated with production and support equipment, process, and utilities.
• Identify and support continuous improvement initiatives.
• Participate in production sustainability goals and seek out innovative solutions to ensure achievement and enhance bioreactor performance.
• Sanitation and upkeep of all production facilities and maintain a high level of a sterile awareness.
• Must operate equipment in a safe manner.
• Must use chemicals (i.e. acids & bases) 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.
• Ensure that the shipping schedule is correctly implemented and report any deviations to Customer Service.
• Maintain a clean, neat, and orderly warehouse area.
• Must be able to lift at least 60lbs.
• 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.

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

• Proficient in MS Office, Excel, and PowerPoint.
• Previous mechanical experience (vehicle shop, machine shop, fabrication shop, etc.)

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

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