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Cipla / Invagen Pharmaceuticals Inc. Manufacturing Operator in Central Islip, New York

Job Description:
Basic understanding of mechanical machinery and the operating principles of control systems.
Executes Batch Record and logbook documentation with detail and accuracy.
Operates pharmaceutical production machinery and executes procedures for manufacturing such as mixing, coating, encapsulating, granulating, drying, milling, blending, compressing and the like.
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 material from dispensing and check dispensed materials and labeling as per BMR.
ear appropriate PPE as stated in the SOP/BMR before initiating process.
Works in collaboration with others as part of a team.
Identifies and assists in the corrective actions of processing related issues.
Executes procedures to complete tasks in a safe and efficient manner.
Ensure adherence to quality standards during all stages of the manufacturing process.
Complete manufacturing documents on time, ensuring accuracy and completeness.
Adheres to all cGMPs, compliance/regulatory mandates and quality requirements.
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.
Responsible for training on all relevant SOPs before start of process/activities in manufacturing.
Comply with company policies and procedures.
Performs other related duties as assigned to meet departmental and Company objectives.

Education Required:
Minimum successful completion of High school diploma.
Solid knowledge of fundamental cGMP and regulatory requirements in a pharmaceutical manufacturing environment.
Basic understanding of mechanical machinery and the operating principles of control systems.
Ability to follow both verbal and written instructions including SOPs and Batch Record documentation.
Demonstrated ability to work in both independent and team environments.
Good knowledge of Health & Safety procedures, including, OH&S Act.
Good interpersonal skills with the ability to work as part of a high-performance team.
Strong mathematical and organizational skills.
Proficient in reading and writing English to understand work instructions and document results.

Preferred Requirements:
4 years experience in pharmaceutical manufacturing
College certificate or University degree in a related discipline is an asset.
Should be able to work in different shifts as per organizational requirement and should be flexible for working additional hours.
Physical Requirements:
This position requires the ability to do heavy lifting / bending frequently.
Stand, walk, sit, climb, balance, stoop or crouch, kneel, reach, push, pull, grasp, feel, talk, and hear.
Exert an amount of force continuously and/or up to 5 pounds of force frequently and/or up to 25 pounds of force occasionally and/or up to 50 pounds of force rarely by utilizing a hand truck to lift, carry, push, pull or otherwise move objects.

Job Summary:
Performs all functions relating to the processing of drug products; consistent with established Current Good Manufacturing Practices (cGMP), customer requirements and in conjunction with all Standard Operating Procedures (SOP). Responsible for the safe and efficient execution of their job duties, while ensuring product compliance to established standards.
Production operator (Granulation/Blending/ Compression/Coating/Encapsulation).