Production Technician USP

Role Summary

Production Technician USP in Pearl River, NY. Mon-Fri, 7:00 a.m. - 3:30 p.m. with overtime as needed. Primary responsibility is operating general manufacturing equipment under close supervision in the production of Flublok Drug Substance in large-scale recombinant protein production operations, within cGMP guidelines. Requires good documentation skills and attention to detail.

Responsibilities

• In-depth understanding of techniques and processes executed on a routine basis.
• Manage all aspects of large-scale bioreactor cell expansion and protein production, including equipment preparation (CIP/SIP), raw materials usage (FIFO), material sampling for analytical testing, filter integrity testing, etc.
• Perform cell analysis and data interpretation of cell culture samples using the cell counter and operate microscope for contamination checks.
• Operate and maintain ancillary equipment (floor scales, turbidity meters, tube welder, tube sealer, peristaltic pumps, etc.).
• Collaborate with other departments to resolve manufacturing quality issues.
• Manage and analyze manufacturing data; identify issues, troubleshoot, propose solutions, and keep management informed.
• Present and explain techniques and results to outside departmental personnel.
• Ensure good documentation practices (GDP) in production records.
• Complete cGMP training and additional trainings as assigned.
• Participate in cleaning of the cGMP facility according to sanitary maintenance SOPs.
• Follow SOPs for materials, personnel, and equipment flow in and out of the cGMP facility.
• Work a flexible schedule, including weekends and holidays as required.
• Coordinate with Compliance regarding deviations and CAPAs and provide information during investigations.
• Other duties as required.

Qualifications

• Education: High School diploma or GED with 1-3 years of experience, or training in a cGMP manufacturing environment, or BS degree with 1-3 years of experience.
• 1-3 years Single Use Bioreactor experience preferred.
• Working knowledge of manufacturing equipment and systems, including valves, filters, piping, HMI systems, and instrumentation for monitoring.
• Familiarity with safe startup, operation, shutdown, and maintenance of process equipment.
• Experience in a regulated manufacturing environment is a plus.
• Strong attention to detail and adherence to safety and quality standards.
• Knowledge of cGMP.
• English fluent, both written and spoken.

Skills

• Technical aptitude in bioprocessing equipment and processes.
• Analytical and data interpretation skills for manufacturing data.
• Proactive problem-solving and effective communication with management and cross-functional teams.
• Good documentation practices and quality discipline.

Education

• High School diploma or GED; or BS degree with relevant manufacturing experience.

Additional Requirements

• May require working in multiple buildings and occasional overtime/off-shift work based on business needs.
• Must be able to lift up to 25 lbs and stand for up to 8 hours per day with breaks.