Production Operator

Sanofi • Pearl River, NY

20d • $24 - $32 • Onsite

About The Position

The Production Operator operates general manufacturing equipment under close supervision in accordance with quality standards, procedures, and safety guidelines to produce Flublok Drug Substance in a cGMP commercial manufacturing facility. The role supports large-scale recombinant protein production and requires strong documentation skills and attention to detail.

Duties include operating, maintaining, cleaning, and sanitizing large-scale cell culture bioreactors and supporting media preparation, infection, harvest, and cell expansion using stainless-steel vessels and single-use bioreactors. The operator uses transfer lines, ancillary equipment, water-for-injection point-of-use taps, and other production equipment. The role also includes preparing workspaces and biosafety cabinets, performing aseptic techniques and preventive maintenance, and completing equipment changeovers.

The operator identifies and troubleshoots operational and equipment problems, communicates issues to management, and assists with manufacturing quality matters. Additional duties may include database entry, cross-training, work in flex areas, and other duties as required. The position requires work on a flexible schedule, including weekends and holidays as required by departmental needs.

Requirements

• High school degree with at least 3–5 years of experience or training in a cGMP manufacturing environment, or a BS degree with 1–3 years of work experience.
• Working knowledge of manufacturing equipment and associated systems, including manual, automated, and control valves; cartridge, bag, and membrane filters; piping systems; HMI systems; and pressure, temperature, and flow instrumentation.
• Familiarity with safe startup, operation, shutdown, and maintenance procedures for process equipment.
• Strong attention to detail and adherence to safety and quality standards.
• Knowledge of cGMP.
• Fluent English, written and spoken.
• Good communication and social skills.
• Ability to lift up to 50 lbs and bend, lift, and move objects as part of the job.

Nice To Haves

• 1–3 years of bioreactor experience preferred.
• Experience in a regulated manufacturing environment, such as food, pharmaceutical, chemical, or industrial manufacturing.
• Proficiency in MS Word and Excel preferred but not required.

Responsibilities

• Operate general manufacturing equipment in accordance with quality standards, procedures, and safety guidelines.
• Perform large-scale bioreactor cell expansion and protein production, including equipment preparation using CIP and SIP, appropriate raw-material and component use according to FIFO, material sampling, and filter integrity testing.
• Operate, maintain, clean, and sanitize bioreactors and associated equipment for media preparation, infection, and harvest.
• Perform cell analysis and interpret cell-culture sample data using a cell counter; operate a microscope for contamination checks.
• Operate and maintain ancillary equipment, including floor scales, turbidity meters, tube welders, tube sealers, and peristaltic pumps.
• Prepare and clean workspaces and biosafety cabinets; perform aseptic techniques, preventive maintenance, and equipment changeovers.
• Identify issues, troubleshoot operational and equipment problems, propose solutions, and keep management informed.
• Interact with other departments to help resolve manufacturing quality issues and present or explain manufacturing techniques and results to outside departmental personnel.
• Ensure good documentation practices when executing and reviewing production records, and manage and analyze manufacturing data.
• Complete required cGMP training and additional training assigned by the manager.
• Clean the cGMP facility in accordance with sanitary maintenance SOPs.
• Follow established SOPs governing the movement of materials, personnel, and equipment into and out of the cGMP facility.
• Work with Compliance to notify relevant personnel of deviations and CAPAs and provide information during investigations.
• Perform database entry, cross-training, operations in flex areas, and other duties as required.
• Work a flexible schedule, including weekends and holidays as required by departmental needs.

Benefits

• Health and wellbeing benefits, including high-quality healthcare, prevention, and wellness programs.
• At least 14 weeks of gender-neutral parental leave.
• Company employee benefit programs may be available to eligible employees.
• Rewards package recognizing employee contributions.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED