Manufacturing Technician (Second Shift)

Kindeva Drug Delivery•Lexington, KY
•Onsite

About The Position

The Manufacturing Technician supports the manufacture of prescription nasal spray medications at Kindeva’s Lexington, Kentucky facility. The role involves operating and monitoring manufacturing equipment and process parameters, preparing equipment and rooms, completing GMP documentation, and maintaining assigned areas. The technician also contributes to team training, validation, preventive maintenance, issue escalation, and improvement efforts. This is an on-site second-shift position, scheduled from 3:00 PM to 1:30 AM, Monday through Thursday and every other Friday. The work environment may involve exposure to highly potent chemical compounds, hazardous materials, and toxic or controlled substances. Employees must follow PPE requirements, safe work methods, and established practices.

Requirements

  • High school diploma or GED.
  • Minimum of 1 year of applicable experience in a GMP-regulated manufacturing environment.
  • Ability to follow SOPs and accurately complete GMP manufacturing documentation, including batch records and logbooks.
  • Strong communication and interpersonal skills and the ability to work effectively in a team environment.
  • Ability to meet applicable requirements for working with controlled substances.
  • Regularly use hands to handle materials and supplies; use computers for extended periods; communicate by telephone and electronically; and stand and walk for extended periods.
  • Occasionally lift and/or move up to 25 pounds, use proper lifting techniques, and remain aware of workplace hazards.
  • Adequate vision to read and execute documentation and perform job tasks compliantly and safely.
  • Follow all site safety procedures.
  • Adhere to PPE requirements, safe work methods, and established practices when working in an environment with potential exposure to highly potent chemical compounds, hazardous materials, and toxic or controlled substances.

Nice To Haves

  • Pharmaceutical manufacturing experience.
  • Experience with sterilization processes or aseptic techniques.

Responsibilities

  • Follow batch records to operate, monitor, and control equipment and process parameters during manufacturing.
  • Complete training and follow Standard Operating Procedures (SOPs) to clean, sanitize, and prepare process equipment and production rooms for manufacturing.
  • Accurately complete required Good Manufacturing Practice (GMP) documentation.
  • Maintain assigned manufacturing areas in accordance with 5S principles.
  • Assist with training and onboarding other manufacturing team members.
  • Assist with the execution of validation protocols for manufacturing and support equipment.
  • Participate in routine preventive maintenance on facilities and equipment.
  • Identify and escalate equipment or process issues affecting manufacturing operations.
  • Recommend manufacturing process or facility improvements and cost-saving opportunities.
  • Perform other duties as assigned by management.
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