Production Machine Operator

Swiss American CDMO; Carrollton (TX); On-site; USD 42,000 - 52,000; Full time

Job summary

Swiss American CDMO is seeking an experienced Production Machine Operator to start up, monitor, and troubleshoot manufacturing lines in a cGMP environment. You will perform routine adjustments, monitor lot numbers, and assist with labeling and packaging tasks to maintain smooth production flow.

The role requires attention to detail, ability to follow detailed instructions, and strong problem-solving skills.

Qualifications

• High School Diploma or GED required.
• Minimum of 2 years experience as a Production Machine Operator in a cGMP environment.
• At least 4 years 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 English communication, both oral and written.
• Strong problem-solving and troubleshooting skills.
• Attention to detail and accuracy.

Responsibilities

• Start machine and observe operation to detect malfunctions.
• Stop machine and report malfunctions to supervisor.
• Make minor adjustments or repairs (opening valves, changing dies, setting guides, clearing damaged containers).
• Inspect filled containers for correct packaging.
• Feed product to conveyors and unload packaged product.
• Count supplies and manage hopper/feeding devices.
• Position and hold containers, operate controls to clean, glue, label, sew, or staple as needed.
• Ensure machine cleanliness and assist in assembly/disassembly of machines.
• Connect bulk tank to machine and verify lot number and expiration with batch ticket.
• Execute line clearance steps at start of production and verify lot printing.
• Change lot numbers during runs and verify with QC and team lead.
• Assist packers with labeling as needed.
• Paletize finished goods and route to QC lane.
• Check for leaks, misprints, or discrepancies in finished goods.
• Maintain counts of finished goods and report to team lead at shift end.
• Perform assembly/disassembly of five or more machines in production.
• Other duties as assigned.

Skills

Mechanical aptitude

Troubleshooting

Detail-oriented

English communication

Instruction following

Problem solving

Education

High School Diploma or GED

Tools

Simplex machine operation

Job description

Essential Duties and responsibilities:Starts machine and observes operation to detect malfunctions of machine.Stops machine and reports malfunction to supervisor.Makes minor adjustments or repairs such as opening valves, changing forming and cutting dies, settingguides, 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.Makes sure machine is clean and helps in putting machine together.Connects the bulk tank to machine and verifies lot number and expiration with batch ticket.Start of production follows steps in BT (line clearance and opens line.)Makes sure Lot number is printing correct on material.Changes Lot number during runs and verifies with QC and team lead.Assist packers in labeling boxes if necessary.Palletizes all finished good and moves pallets to designated QC lane.Checks all finished good 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 theshift.Assembly/Disassembly of five or more machines in productionOther duties may be assigned.Essential Skills and Qualifications: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.Work Environment:The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. The noise level in the work environment is usually moderate.Physical Demands:The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Must be able to lift up to 50lbs on a regular basis.The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor. Employees will be required to perform overtime (OT) duties as requested by their manager.Candidates selected for employment will be required to complete a pre-employment screening, including a drug test, employment verification, and education verification.