Pharmaceutical Coating Operator

TITLE: MANUFACTURING OPERATOR (COATING)

DOMAIN: PHARMACEUTICALS/BIOTECHNOLOGY/CLINICAL RESEARCH

LOCATION: USA - CENTRAL ISLIP/HAUPPAUGE NY FACILITIES

SUMMARY:

This position is a Production Operator assigned to support coating. This hourly laborer and individual contributor role will report to a Front-Line Supervisor. This position may be at the Companys manufacturing units in Hauppauge or Central Islip, New York.

THERE ARE TWO SHIFTS AVAILABLE:

* 1st Shift 07:00 am 03:30 pm (3 positions)

* 2nd Shift 03:00 pm 11:30 pm (3 positions)

ROLES & RESPONSIBILITIES:

* The person must be able to know how to operate pharmaceutical production machinery independently.

* Execute procedures for manufacturing processes by batch manufacturing record (BMR) and Standard Operating Procedures (SOP) requirements.

* Perform machine changeovers, cleaning, and setup as per SOPs. Ensure the proper area & equipment cleanliness and set up in the 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 the 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 maintaining 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 from 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 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 requirements 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 working hours; ability to ascent/decent ladders; and able to lift up to 35 pounds.

* Must be able to move pallets/equipment weighing about 200 300 kgs using suitable moving equipment like pallet jacks.

Permanent