Production Operator

About the Job

Primary responsibility of the incumbent will be operation of general manufacturing equipment under close supervision in accordance with current relevant quality standards or standardized procedures and within safety guidelines in the production of Flublok Drug Substance in the large-scale recombinant protein production operations of the cGMP commercial manufacturing facility. Requires good documentation skills and attention to detail.

Duties will include the operation, maintenance, cleaning and sanitization of large-scale cell culture bioreactors and associated operations such as media preparation, infection, and harvest. Activities will include executing techniques such as large-scale bioreactor cell expansion with the use of stainless-steel vessels and single use bioreactors (SUBs) including transfer lines, ancillary equipment (tube welders, tube sealers, peristaltic pumps), use of water-for-injection (WFI) point of use taps, etc. Other duties will include the cleaning and preparation of workspaces and biosafety cabinets.

Proficiency in aseptic technique, preventive maintenance, and changeovers for area equipment, including biosafety cabinets, magnetic mixers, in-process testing equipment (cell analyzer, microscope) required. The incumbent should have the ability to identify, troubleshoot and participate in the resolution of operational and equipment problems as they arise in the large-scale Bioreactor and Media Preparation areas with minimum supervision and effective communication to management.

Main Responsibilities

• In depth understanding of techniques and processes being executed on routine basis.
• Responsible for all aspects of large-scale bioreactor cell expansion and protein production including equipment preparation (CIP and SIP), appropriate use of raw materials and components (FIFO), material sampling for applicable analytical testing, filter integrity testing, etc.
• Perform cell analysis and data interpretation of cell culture samples with the use of the cell counter, including operation of microscope for contamination checks.
• Responsible for the operation and maintenance of ancillary equipment such as floor scales, turbidity meters, tube welder, tube sealer, peristaltic pumps, etc.
• Interacts with other departmental personnel to assist in resolving manufacturing quality issues.
• Technician should have the ability to manage and analyze manufacturing data.
• Ability to take initiative to identify issues, troubleshoot, propose solutions, and keep management informed.
• Ability to present and explain techniques and results of manufacturing processes with outside departmental personnel.
• Ensure good documentation practices (GDP) in execution and reviews of production records.
• Responsible for all required cGMP training including additional training assigned by their manager.
• Participates in the cleaning of the cGMP facility in accordance with sanitary maintenance SOP.
• Follows established SOPs for the flow of materials, personnel, and equipment in and out of the cGMP facility.
• Work a flexible work schedule, weekends and holidays as required, and as needed by department.
• Work with Compliance regarding notification of deviations and CAPAs as they occur and provides information during investigations.
• Other duties as they are required.

About You

Education: High School degree with at least 3-5 years' experience or training in a cGMP manufacturing environment OR BS degree with 1-3 years' of work experience. 1-3 years Bioreactor experience preferred.

Working knowledge of manufacturing equipment and associated systems, including but not limited to: Valves (manual, automated, control), Filters (various types such as cartridge, bag, and membrane filters), Piping systems (materials, fittings, layout, and flow principles), HMI (Human-Machine Interface) systems for equipment monitoring and control, Instrumentation for pressure, temperature, and flow monitoring.

Familiarity with safe startup, operation, shutdown, and maintenance procedures for process equipment. Experience working in a regulated manufacturing environment (e.g., food, pharmaceutical, chemical, or industrial) is a plus. Strong attention to detail and adherence to safety and quality standards. Knowledge of cGMP. English fluent, both written and spoken. Good communication and social skills. MS Word and Excel proficiency preferred but not required. Must be able to lift up to 50 lbs., and bend/lift/move objects as part of the job.