Manufacturing Operator

Manufacturing Operator

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This position carries out and is responsible for, as assigned, all day-to-day manufacturing activities in the areas of Formulation and Filling.  The Formulation process includes the critical steps of very detailed measurements of raw material components along with specific addition and mixing processes for the proper manufacturing of parenteral (liquid) pharmaceutical products. The product is then transferred in a highly controlled process to the Filling operation, where the product is dosed into final containers and sealed.  This process is done via automated process, however there is extensive oversight needed to properly carry out and document the process.

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Manufacturing Operator

This position carries out and is responsible for, as assigned, all day-to-day manufacturing activities in the areas of Formulation and Filling.  The Formulation process includes the critical steps of very detailed measurements of raw material components along with specific addition and mixing processes for the proper manufacturing of parenteral (liquid) pharmaceutical products. The product is then transferred in a highly controlled process to the Filling operation, where the product is dosed into final containers and sealed.  This process is done via automated process, however there is extensive oversight needed to properly carry out and document the process.

RESPONSIBILITIES AND DUTIES

  • Execution of Batch Record steps per instructions, including performance tasks as well as collection and recording of data for use in monitoring and measuring the process.
  • Performance of the Formulation of product and necessary transfer to Filling.
  • Setup, Operation, and Monitoring of the Automated Filling System.
  • Feedback of information to management, technical services, and engineering for improvement opportunities related to procedures, batch records, and equipment/facility outfitting.
  • Properly follow cGMP requirements in the manufacturing areas.
  • Perform scheduled cleaning/sanitizations of production areas.
  • Ensure compliance with all department SOP’s.
  • Perform assigned tasks with care to ensure all quality standards are maintained to manufacture the best possible product.
  • Perform assigned tasks expeditiously to help keep all projects on schedule.
  • Ensure manufacturing areas are well maintained.
  • Ensure all equipment is cleaned, maintained, and ready for cGMP activities.
  • Adhere to all safety practices and compliance in all areas.
  • Other miscellaneous duties as assigned

QUALIFICATIONS, EDUCATION AND/OR EXPERIENCE REQUIREMENTS

  • High School Diploma/GED
  • 5+ years of production-related experience in the Pharmaceutical industry
  • Work individually and with groups, with excellent communication skills
  • Problem solving skills and attention to detail very important
  • Basic math skills, and experience with computer systems & business applications a plus
  • Ability to enter and collect data from various computer systems.
  • Attention to detail, and ability to read and follow written instructions.
  • Excellent written and verbal communication skills
  • Integrity with respect to maintenance of proprietary and confidential information
  • Knowledge of aseptic technique and safe laboratory practices, including the proper procedures for handling chemicals and samples a plus

SPECIAL DEMANDS

  • Must be able to lift 50 lbs.
  • May require working in cold conditions.
  • May be exposed to prolonged standing and walking.
  • May be exposed to harsh chemicals and reagents.
  • Able to wear Personnel Protective Equipment, i.e. safety glasses, face shield, respirator, latex/nitrile gloves, safety shoes, and hearing protection.
  • Must be able to gown into aseptic clothing to enter manufacturing areas.

TOOLS, EQUIPMENT AND OTHER RESOURCES USED

  • Scales, balances, pH meters, and related equipment.
  • Various software applications sustained by a Windowsä (Excel, Word, PowerPoint, etc.)
  • HMI, Human Machine Interface / Process Equipment.

PERFORMANCE DEMANDS

Characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

GENERAL

  • Ability to read, write, speak and understand English.
  • Physical Activity
  • Moderate physical activity
  • This position will require frequent walking, sitting and/or standing for extended periods of time, carrying, heavy lifting (max. 50 lbs), reaching while standing, gripping and twisting hand movements, finger control and other general repetitive motions (for more than four [4] hours per day)
  • Able to wear latex or nitrile gloves, dust mask or respirator, and safety glasses as required.
  • Ability to read and understand applicable materials
  • Manual dexterity to operate laboratory equipment and calculator/computer
  • Able to read and interpret test results and instrument specifications
  • Able to complete training as required

WORKING CONDITIONS

  • Work is performed in a typical interior/office, laboratory environment, Manufacturing areas, and clean room environments.
  • Work environment involves exposure to potentially dangerous materials and situations that require following extensive safety precautions and may include use of protective equipment.
  • The noise level is usually moderate.
  • This position will frequently be involved with radiant/electrical energy, solvents, grease, oil, irritants, acids, bases, and other hazardous chemicals, electro-mechanical hazards, flammable materials and bio-hazards.

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