Production Technician USP

Role Summary

Production Technician USP at Pearl River, NY. The role involves operating general manufacturing equipment in a cGMP environment to support the production of Flublok Drug Substance, including bioreactor operations, equipment maintenance, and adherence to quality and safety standards. Requires strong documentation, aseptic technique, and cross-functional collaboration.

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.

Qualifications

• Education: High School diploma or GED with 1-3 years‚Äô experience OR training in a cGMP manufacturing environment OR BS degree with 1-3 years of work experience.
• 1-3 years Single Use Bioreactor experience preferred.
• Working knowledge of manufacturing equipment and associated systems, including but not limited to:
  • Valves (manual, automated, control)
  • Filters (cartridge, bag, and membrane)
  • 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.

Skills

• aseptic technique
• preventive maintenance
• data analysis and interpretation
• documentation practices (GDP)
• problem solving and troubleshooting

Education

• High School diploma or GED; or BS degree with related experience