Production Operator

Sanofi • Pearl River, NY

9d • Onsite

About The Position

The Production Operator operates general manufacturing equipment under close supervision and in accordance with applicable quality standards, standardized 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.

The position includes operating, maintaining, cleaning, and sanitizing large-scale cell culture bioreactors and related equipment and processes, including media preparation, infection, and harvest. Work involves stainless-steel vessels and single-use bioreactors, transfer lines, ancillary equipment, and water-for-injection points of use. The operator also prepares workspaces and biosafety cabinets and performs aseptic techniques, preventive maintenance, and equipment changeovers. The role includes identifying and troubleshooting operational or equipment issues, communicating with management, supporting manufacturing quality investigations, entering data, and cross-training or working in flex areas as business needs require.

The operator works with other departmental personnel and Compliance, maintains cGMP training, follows SOPs and good documentation practices, participates in facility cleaning, and may work a flexible schedule including weekends and holidays as needed. The position requires the ability to lift up to 50 pounds and bend, lift, and move objects.

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 skills, written and spoken.
• Good communication and social skills.
• Ability to lift up to 50 pounds 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, is a plus.
• Proficiency in MS Word and Excel is preferred but not required.

Responsibilities

• Operate general manufacturing equipment to produce Flublok Drug Substance in accordance with applicable quality standards, procedures, and safety guidelines.
• Perform large-scale bioreactor cell expansion and protein production, including equipment preparation through CIP and SIP, raw-material and component use according to FIFO, material sampling for analytical testing, and filter integrity testing.
• Operate, maintain, clean, and sanitize large-scale cell culture bioreactors and associated equipment and processes, including media preparation, infection, and harvest.
• Use stainless-steel vessels, single-use bioreactors, transfer lines, water-for-injection point-of-use taps, and ancillary equipment.
• Perform cell analysis and interpret data from cell culture samples using a cell counter, and operate a microscope for contamination checks.
• Operate and maintain ancillary equipment, including floor scales, turbidity meters, tube welders, tube sealers, and peristaltic pumps.
• Clean and prepare workspaces and biosafety cabinets; perform aseptic techniques, preventive maintenance, and equipment changeovers.
• Identify, troubleshoot, and help resolve operational, equipment, and manufacturing quality issues; communicate issues and proposed solutions to management.
• Manage and analyze manufacturing data and present or explain manufacturing techniques and results to personnel outside the department.
• Maintain good documentation practices when executing and reviewing production records.
• Complete required cGMP training and additional training assigned by the manager.
• Participate in cGMP facility cleaning according to the sanitary maintenance SOP and follow established SOPs for movement of materials, personnel, and equipment in and out of the facility.
• Work with Compliance to notify relevant parties of deviations and CAPAs and provide information during investigations.
• Perform database entry, cross-training, flex-area operations, and other duties as required.
• Work a flexible schedule, including weekends and holidays, as required by the department.

Benefits

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

What This Job Offers

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