Production Machine Operator III

Swiss American CDMOCarrollton, TX
Onsite

About The Position

The Production Machine Operator III is responsible for operating and maintaining production machinery, ensuring product quality, and adhering to cGMP standards. This role involves starting and monitoring machines, performing minor adjustments and repairs, inspecting finished products, and managing production counts. The operator will also be involved in machine assembly/disassembly and assisting with packaging and palletizing. This position requires a strong technical aptitude, the ability to follow detailed instructions, and excellent problem-solving skills. The operator must be able to work independently and as part of a team, ensuring that all production activities comply with regulatory requirements.

Requirements

  • High School Diploma or GED required.
  • Minimum of 2 years of experience as a Production Machine Operator in a cGMP environment (pharmaceutical, nutraceutical, FDA-regulated, or skincare).
  • At least 4 years of total experience in production or packaging within a cGMP environment.
  • Technical or mechanical aptitude is essential.
  • Experience operating at least five different production or packaging machines, including Simplex.
  • Excellent oral and written communication skills in English.
  • Basic mathematical skills, including addition, subtraction, multiplication, and division.
  • Ability to perform basic calculations related to production (e.g., yields, cycle times).
  • Ability to follow detailed instructions and work independently.
  • Strong problem-solving and troubleshooting skills.
  • Ability to identify and resolve minor equipment malfunctions.
  • Attention to detail and the ability to maintain accuracy.
  • Must be able to lift up to 50lbs on a regular basis.
  • Ability to complete a pre-employment screening, including a drug test, employment verification, and education verification.

Responsibilities

  • Starts machine and observes operation to detect malfunctions.
  • Stops machine and reports malfunction to supervisor.
  • Makes minor adjustments or repairs such as opening valves, changing forming and cutting dies, setting guides, or clearing away damaged product containers.
  • Inspects filled container to ensure that product is packaged according to specifications.
  • Feeds product to conveyors, hoppers, or other feeding devices, and unloads packaged product.
  • Counts supplies on spindles or places supplies in hopper or other feeding devices.
  • Positions and holds container in machine and depresses pedal, presses button, or moves lever to clean, glue, label, sew, or staple container.
  • Ensures machine is clean and assists in putting machine together.
  • Connects the bulk tank to machine and verifies lot number and expiration with batch ticket.
  • Follows steps in BT for start of production (line clearance and opens line).
  • Ensures Lot number is printing correctly on material.
  • Changes Lot number during runs and verifies with QC and team lead.
  • Assists packers in labeling boxes if necessary.
  • Palletizes all finished goods and moves pallets to designated QC lane.
  • Checks all finished goods for leakers, miss prints or any discrepancies during production.
  • Keeps count of finished goods produced by operator and submits information to team lead at end of the shift.
  • Performs assembly/disassembly of five or more machines in production.
  • Performs other duties as assigned.
  • Performs overtime duties as requested.
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