Job Summary: This position is a Manufacturing Operator assigned to support Granulation, Blending, Compression, Coating, and Encapsulation. This is an hourly laborer and individual contributor role that will report to a Front-Line Supervisor. This position may be based at the Company's manufacturing units in Hauppauge or Central Islip, New York. There are two shifts available: 1st Shift 07:00 am - 03.30pm 2nd Shift 03:00 pm - 11:30 pm Job Responsibilities: Person must be able to know how to operate pharmaceutical production machinery independently. Execute procedures for manufacturing processes in accordance with batch manufacturing record (BMR) and Standard Operating Procedures (SOP) requirements. Perform machine changeovers, cleaning and set up as per SOPs. Ensure the proper area & equipment cleanliness and setup in stipulated time. Prepare a room and equipment for line clearance, replace room filters, Ensure verification and calibration of balance/scale and check pressure differential for the rooms. Ensure line clearance before initiating manufacturing activities in each area. Receive/transfer material from/to dispensing/manufacturing storage and check dispensed materials/final mix blend/compressed tablets and labeling as per BMR. Wear appropriate personal protective equipment (PPE) as stated in the SOP/BMR before initiating process. Able to operate applicable equipment independently as per area of operation. Troubleshoot and make appropriate adjustments to equipment to maintain product/BMR specifications. Ensure adherence to quality standards during all stages of the manufacturing process. Complete manufacturing documents on time, ensuring accuracy and completeness. Responsible for training on all relevant SOPs and always maintain compliance with related SOPs and current Good Manufacturing Practices (cGMP) in the manufacturing process. Perform duties through the proper, safe use of equipment, according to Health & Safety procedures and Equipment Manuals. Flexible to work extended hours, to achieve manufacturing schedule when needed. Should maintain discipline and comply with company policies and procedures. Should perform entire duties as communicated time to time by department management/designee. Minimum Requirements: Solid mechanical aptitude and troubleshooting skills. Minimum of 2 years of experience working in industrial environments such as pharmaceutical manufacturing and related settings. Must have excellent communication skills. Must be able to clearly communicate in English (verbally and in writing). Positive, professional attitude toward work and willingness to cooperate with co-workers and supervisors. Must be able to work different shifts as per organizational requirement and should be flexible for working additional hours such as overtime and weekends. Physical Requirements: Should not have any restriction to work with powder containing active pharmaceutical ingredients. This position requires the ability to do heavy lifting / bending frequently. Long periods of standing up/walking during the working hours; ability to ascent/decent ladders; and able to lift to 35 pounds. Must be able to move pallets/equipment weighing about 200 – 300 kgs using suitable moving equipment like pallet jacks.
