Manufacturing Operator

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.  

Essential Duties and Responsibilities

• Executes Batch Record and logbook documentation with detail and accuracy.
• Executes the procedures used to clean pharmaceutical production equipment and facilities.
• Operates pharmaceutical production machinery and executes procedures for manufacturing such as dispensing, mixing, coating, encapsulating, granulating, drying, milling, blending, compressing and the like.
• Executes total changeovers.
• Identifies and assists in the corrective actions of processing related issues.
• Maintains production reporting for assigned work unit operation.
• Performs required in-process product quality checks and documents accurately.
• Executes procedures to complete tasks in a safe and efficient manner.
• Works in collaboration with others as part of a team.
• Assists with on the job training of other production trainees and operators.
• May determine methods and procedures on new assignments and may provide assistance to other support personnel.
• Uses ability to complete tasks in a compliant and safe manner.
• Effectively communicates issues to supervisor.
• Adheres to all cGMPs, compliance/regulatory mandates and quality requirements.
• Assists in the identification and implementation of continuous improvement opportunities.
• Performs other related duties as assigned to meet departmental and Company objectives.

KNOWLEDGE/SKILLS/ABILITIES

• Knowledge of Metric and English weighing and measurements systems.
• Basic understanding of mechanical machinery and the operating principles of control systems.
• Demonstrated mathematical ability in addition, subtraction, multiplication, division, ratios and percentages.
• Ability to use a calculator.
• Ability to follow both verbal and written instructions including SOP's and Batch Record documentation.
• Accurate and precise in recording data and batch information.
• Demonstrated ability to work in both independent and team environments.
• Proficient in reading and writing English to understand work instructions and document results.
• Demonstrated ability to operate pharmaceutical processing equipment.
• Demonstrated ability to meet required standards of cGMPs.
• Demonstrated understanding of the unit operations and the ability to assist with on-the-job training of manufacturing trainees and operators.

 EDUCATION/EXPERIENCE

• High school diploma or general education diploma (GED).
• Two years' related experience or equivalent technical training/certification preferred; or a combination of related experience and technical training/certification.

 REQUIREMENTS

• Successful completion of required training for Manufacturing Trainee.

Work environment

The physical demands described here are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job the individual is required to:

1. Stand, walk, sit, climb, balance, stoop or crouch, kneel, reach, push, pull, grasp, feel, talk, and hear.

1. Have clarity of vision at 20 feet or more and 20 inches or less with the ability to judge distance and space relationships, bring object into sharp focus and see up and down or to the right or left while fixed on a point. Must also have the ability to identify and distinguish colors.

3. 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.

 The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this job:

1. Sufficient noise to occasionally cause the individual to shout in order to be heard above the ambient noise level.
2. Individual is in a proximity to moving mechanical parts, electrical current and exposure to chemicals.
3. Atmospheric conditions sometimes expose individual to dust, for which protective equipment is available.
4. Individual may be required to wear respiratory devices that include but are not limited to: Air Purifying Respirators (APR) which include half-face and full-face negative pressure respirators, hooded powered air purifying respirators, or Supplied Air Respirators (SAR), which include hooded or full face supplied air respirators.

Current Openings for Manufacturing Operator Jobs at Nesher Pharmaceuticals (USA) LLC