Production Technician

Sanofi; Pearl River (NY); On-site; USD 52,000 - 78,000; Full time

Job summary

Sanofi US Services in Pearl River, NY is hiring for a downstream processing technician to operate and maintain downstream processing equipment in a cGMP facility. You will perform aseptic sampling, calibration checks, and ensure GDP-consuming documentation while supporting purification steps and buffer preparation.

The role requires attention to detail, ability to work cross-functionally, and flexibility to cover extended shifts and weekends as production schedules demand.

Qualifications

• High School Diploma with at least 1 year of work experience.
• Bachelor’s Degree with no prior experience.
• Training within a cGMP manufacturing environment is preferred.
• General knowledge of cGMP, GDP, SOPs.
• English fluent, both written and spoken.
• Good communication and social skills.
• BEVS manufacturing process knowledge is desired but not required.

Responsibilities

• In depth understanding of techniques and processes being executed on routine basis.
• Responsible for all aspects of downstream and buffer preparation including equipment preparation (CIP and SIP), appropriate use of raw materials and components (FIFO), weighing and dispensing of raw materials and intermediate solutions, material sampling for applicable analytical testing, filter integrity testing, etc.
• Responsible for the operation and maintenance of ancillary equipment such as pH/conductivity meters, 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.
• 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.

Skills

English fluent

Communication

Aseptic technique

GDP/cGMP knowledge

Data analysis

Education

High School Diploma

Bachelor’s Degree

cGMP manufacturing training

Job description

About The Job

Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster.

We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and meticulous eye for detail of our Manufacturing & Supply teams. With your talent and ambition, we can do even more to protect people from infectious diseases and bring hope to patients and their families.

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 downstream processing (Clarification and Purification) and buffer preparation areas of the cGMP commercial manufacturing facility. In addition, perform aseptic sampling (Environmental monitoring sampling, WFI, PUW and Clean Steam Sampling).

Requires good documentation skills and attention to detail. Duties will include the operation, maintenance, cleaning and sanitization of all downstream processing equipment such as stainless-steel vessels including transfer lines, ancillary equipment (tube welders, tube sealers, peristaltic pumps), use of water-for-injection (WFI) point of use taps, etc. Activities will include executing techniques such as large-scale centrifugation, depth filtration, chromatography column purification and packing, tangential flow filtration, and clean-in-place and steam-in-place of process equipment.

Other duties will include the cleaning and preparation of workspaces and biosafety cabinets. The incumbent should be proficient in aseptic technique, preventive maintenance, and changeovers for area equipment, including biosafety cabinets, magnetic mixers, in-process testing equipment (pH / conductivity meters and turbidity meters). Secondary responsibilities will be to aid in the troubleshooting of problems as they arise in downstream and buffer preparation areas. Business needs may also require database entry, cross training and operations in flex areas.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

About Sanofi

We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Main Responsibilities

• In depth understanding of techniques and processes being executed on routine basis.
• Responsible for all aspects of downstream and buffer preparation including equipment preparation (CIP and SIP), appropriate use of raw materials and components (FIFO), weighing and dispensing of raw materials and intermediate solutions, material sampling for applicable analytical testing, filter integrity testing, etc.
• Responsible for the operation and maintenance of ancillary equipment such as pH / conductivity meters, 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.
• 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

Requisite Educations/Skills

• High School Diploma with at least 1 year of work experience
• Bachelor’s Degree with no prior experience
• Training within a cGMP manufacturing environment is preferred
• General knowledge of cGMP, GDP, SOP’s
• English fluent, both written and spoken
• Good communication and social skills
• Basic understanding of the Baculovirus Expression Vector System (BEVS) manufacturing process is desired but not required

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job and include the ability to stand over intervals of several hours at a time, ability to bend, squat, and reach, and ability to lift, push, or pull various amounts of weight up to approximately 50 lbs. The work environment characteristics described here are representative of those an employee to encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. May involve work with hazardous materials.

Based on production schedules, different start time scenarios may occur, requiring a flexible work schedule for the candidate. Ability to accommodate production requirements that may require 50+ hour workweeks, including 2nd shift or split shift hours, extended day hours and weekends. This role requires frequent work on weekends depending on production demands.

Why Choose Us

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

Sanofi US Services and its U.S. affiliates are Equal Opportunity employers committed to a culturally inclusive workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.