Sanofi
USA - Manufacturing Associate I (Manufacturing/Quality) 1st Shift (contract)
Sanofi, Pearl River, New York, United States, 10965
USA - Manufacturing Associate I (Manufacturing/Quality) 1st Shift (contract)
Sanofi’s contingent workforce program, FLEXT Direct, is seeking a Manufacturing Associate I for a 12‑month contract. The incumbent will operate general manufacturing equipment under close supervision in accordance with cGMP and quality standards in the media, buffer and solution preparation areas of the cGMP commercial manufacturing facility. The role requires good documentation skills, attention to detail and proficiency in aseptic technique and preventive maintenance.
Responsibilities
Operate and maintain media, buffer and solution formulation equipment including CIP/SIP, mixing units, bulk pumps and in‑process testing instruments.
Follow SOPs for raw material use (FIFO), weighing, dispensing, sampling and filter integrity testing.
Perform preventive maintenance, cleaning, sanitization and changeovers of equipment such as biosafety cabinets, magnetic mixers and tube welders.
Assist in troubleshooting and resolve manufacturing quality issues in collaboration with other departments.
Analyze manufacturing data and support compliance with GDP and cGMP documentation.
Participate in the cleaning of the cGMP facility and in CAPA investigations.
Work a flexible schedule, including weekends and holidays, as required by the department.
Other duties as required.
Prerequisite Education / Skills
High school diploma with at least 2 years of experience in a cGMP manufacturing environment.
General knowledge of cGMP, GDP and SOPs.
Good communication and interpersonal skills.
Basic understanding of the Baculovirus Expression Vector System (BEVS) manufacturing process is desirable but not required.
Physical demands include lifting up to approximately 50 lbs. The work environment may involve hazardous materials. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this job.
Employment type: Contract. Seniority level: Entry level.
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Responsibilities
Operate and maintain media, buffer and solution formulation equipment including CIP/SIP, mixing units, bulk pumps and in‑process testing instruments.
Follow SOPs for raw material use (FIFO), weighing, dispensing, sampling and filter integrity testing.
Perform preventive maintenance, cleaning, sanitization and changeovers of equipment such as biosafety cabinets, magnetic mixers and tube welders.
Assist in troubleshooting and resolve manufacturing quality issues in collaboration with other departments.
Analyze manufacturing data and support compliance with GDP and cGMP documentation.
Participate in the cleaning of the cGMP facility and in CAPA investigations.
Work a flexible schedule, including weekends and holidays, as required by the department.
Other duties as required.
Prerequisite Education / Skills
High school diploma with at least 2 years of experience in a cGMP manufacturing environment.
General knowledge of cGMP, GDP and SOPs.
Good communication and interpersonal skills.
Basic understanding of the Baculovirus Expression Vector System (BEVS) manufacturing process is desirable but not required.
Physical demands include lifting up to approximately 50 lbs. The work environment may involve hazardous materials. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this job.
Employment type: Contract. Seniority level: Entry level.
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