Manufacturing Technician

3 weeks ago

Lexington KY USA, United States Kindeva Drug Delivery Full time
Job Summary:

The Manufacturing Technician is responsible for ensuring the efficient and effective operation of process equipment used to manufacture sterile nasal spray drug products. This includes cleaning, sanitizing, and maintaining equipment, as well as completing associated documentation.

Key Responsibilities:
  • Follow Production Batch Records (PBRs) to operate, monitor, and control equipment and process parameters during manufacture.
  • Follow Standard Operating Procedures (SOPs) to clean, sanitize, and prepare process equipment for manufacturing.
  • Complete PBRs, Log Books, Forms, and other documentation.
  • Assist in the compilation and review of lot records before submitting to Quality Assurance.
  • Maintain assigned manufacturing area neat, clean, and well-stocked with supplies.
  • Assist with the training of other manufacturing team members.
  • Coordinate manufacturing, calibration, and maintenance activities with other departments.
  • Assist with the writing, executing, and reviewing validation protocols for manufacturing/support equipment.
  • Independently champion manufacturing or facility-related improvement projects.
  • Participate in the performance of routine preventive maintenance on facilities and equipment.
  • Help identify continuous improvement and cost savings opportunities.
  • Adhere to cGMPs, SOPs, and Safety policies.
Requirements:
  • High School diploma or GED.
  • 0-5 years of applicable experience working in a pharmaceutical manufacturing environment.
  • Experience with sterilization processes or aseptic technique preferred.
  • Good written communication skills to write SOPs and other cGMP documents.
  • Qualified to work with controlled substances.
  • Strong interpersonal skills and the ability to work well in a team environment.
Physical Demands:
  • Employee is required to regularly use hands to execute documentation, setup and operate equipment, and handle materials.
  • Employee is required to regularly stand and walk for extended periods of time.
  • Employee must occasionally lift and/or move up to 60 pounds.
  • Specific vision abilities requirements include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust and focus.
  • Employee is required to wear all required Personal Protective Equipment.
  • Ability to use proper lifting techniques and be conscious of work area hazards.
  • Employee is required to follow all cGMP and safety procedures.

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