Production Technician

About The Job

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Production Technician

Pearl River, NY

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.

Must possess strong 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, 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 include cleaning and preparation of work spaces and biosafety cabinets, proficiency 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 troubleshooting problems as they arise in downstream and buffer preparation areas. Business needs may also require database entry, cross training and operations in flex areas.

• 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.

• High School Diploma with at least 1 year of work experience.
• Bachelors 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.
• 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…