Biofarma Srl

Operator, Granulation/Blending Operator 1

Location: 1300 Airport Road, North Brunswick NJ

Reports to: Production, Supervisor

Role Overview

The Granulation/Blending Operator is responsible for the operation and set up of granulators, drying oven, blenders, screening equipment etc. in accordance with company standard operating procedures. The position includes set up, operation, cleaning, and preventative maintenance of all related equipment. The Operator is accountable for overall performance including safety, quality, shrink, attainment, and production efficiency. Operators must be capable of operating multiple like machines at one time and learning to operate a variety of equipment within the manufacturing area.

Areas of Responsibility

Follow batch records, SOP's, and cGMP's guidelines to ensure product specifications and tolerances are met. Ensures full compliance with Company policies, procedures, GMP's, Ethical Business Practice, and SOP's at all times. Ensures that product meets applicable quality standards. This includes inspection for quality during operation and performing all required sampling and testing. Complete all labeling and inventory movements to ensure accurate inventory control.

Dismantle and clean any accessories and equipment while also maintaining a clean work area. Train in the operation, cleaning and set-up of the following pieces of equipment as well as new equipment: Rapid Mixer Granulator: 100L & 600L and planetary mixer Fluid bed dryer/processor Tray Drying Ovens Fitz mill/Multi mill Double cone/V- blenders: 6cu. ft. to 150 cu. ft. Screening/ sieving equipment Fill in appropriate logbooks for equipment and rooms. Perform all material handling of products and components.

Correctly document all steps on batch record. Participate in any investigation for a deviation involving a batch record. Maintain proper gowning and hygiene to ensure integrity of the product as per company policies. Works extended hours and occasional weekend overtime. Other duties as assigned

Requirements

Education & Qualification: High school graduate or GED equivalent 3+ years Granulating/Blending Operator experience Minimum of one (1) year work experience in nutritionals, supplements, food, or pharmaceutical manufacturing industries 6-12 months experience Operates blending, screening & milling machines. Must be proficient in proper setup and operation of blenders

Skills & Ability Demonstrates ability to work in a team and assist others. Able to follow written instructions precisely and perform basic math calculations as required. Understands and is knowledgeable of cGMP, OSHA standards etc. Mechanically inclined to understand inner workings of equipment. Demonstrates the ability to read and write basic English in order to be able to understand the industry regulated instruction sheets

Physical Requirements (lifting, etc.): Ability to lift up to 50 lbs.; occasionally lift and move up to 75 pounds. Must stand and walk on the production floor for a minimum of 6 hours per shift Uses hands to finger, handle, feel, or operate objects or controls, lifting to waist height and/or above shoulder height, frequent bending from the waist, or squatting, walking short distances. Occasionally works from a rolling ladder or step stool, must be able to lean over equipment as well as kneeling on the floor to clean under the equipment.

Must be able to wear all PPE including a lab coat, face mask, booties, gloves, safety glasses/goggles, and respirators. Work Environment (Office, Warehouse, temperature extremes, etc.): Work is regularly performed inside a manufacturing environment where temperatures can be moderate, exposure to dust, odors, noise, and fumes. The noise level is usually moderate. Employees can be exposed daily to chemicals and cleaning agents.

1st shift - 7:00 AM to 3:30 PM