Manufacturing Associate

Manufacturing Associate I

Location:

Pearl River, NY | Duration: 12 Months | Pay Range: $23.00/hr on W2 to $25.00/hr on W2

Base pay range: $23.00/hr - $25.00/hr

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 media, buffer and solution preparation areas of a cGMP commercial manufacturing facility. Requires good documentation skills and attention to detail. Duties include operation, maintenance, cleaning and sanitization of media and buffer equipment, cleaning and preparation of work spaces and biosafety cabinets, proficiency in aseptic technique, preventive maintenance, and changeovers for area equipment.

Secondary responsibilities include troubleshooting problems arising in the media, buffer and solution preparation areas. Cross training and operations in flex areas may be required.

• In-depth understanding of techniques and processes being executed on routine basis.
• Responsible for all aspects of media, buffer and solution formulation 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, osmometer, tube welder, tube sealer, peristaltic pumps, etc.
• Interact with other departmental personnel to assist in resolving manufacturing quality issues.
• Technician should have the ability to manage and analyze manufacturing data.
• 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.
• Participate in the cleaning of the cGMP facility in accordance with sanitary maintenance SOP.
• Follow established SOPs for the flow of materials, personnel, and equipment in and out of the cGMP facility.
• Work a flexible work schedule, including weekends and holidays as required, and as needed by department.
• Work with Compliance regarding notification of deviations and CAPAs as they occur and provide information during investigations.
• Other duties as required.

• High School degree with at least 2 years of work experience, or training within a cGMP manufacturing environment.
• General knowledge of cGMP, GDP, SOP’s.
• Good communication and social skills.
• Basic understanding of the Baculovirus Expression Vector System (BEVS) manufacturing process is desired but not required.

Requires physical demands of 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.

Entry level

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