Manufacturing Associate I

Immediate need for a talented Manufacturing Associate I. This is a 12+ months contract opportunity with long-term potential and is located in Pearl River, NY (Onsite). Please review the job description below and contact me ASAP if you are interested.

Job ID: 25-88552

Pay Range: $20 - $25/hour.  Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

Key Responsibilities:

• 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.
• 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.
• In-depth understanding of techniques and processes being executed on a 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 the department.
• Work with Compliance regarding notification of deviations and CAPAs as they occur and provides information during investigations.
• Other duties as they are required.
• 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.
• 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

Key Requirements and Technology Experience: 

• Key Skills; cGMP, GDP, SOP’s 
• Downstream and Buffer Preparation
• Use of raw materials and components
• 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
• 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

Our client is a leading Biopharmaceuticals Industry and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.

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