Machine Operator I

MillenniumSoft Inc; Burlington (NC); On-site; USD 27,000 - 35,000; Full time

Job summary

MillenniumSoft Inc. in Burlington, NC seeks a Machine Operator for a 1-year contract supporting FDA-regulated, high-volume manufacturing. The role operates 9:00 PM–7:00 AM, with a 40-hour week (Mon–Thu schedule) and potential overtime. You will handle BD-SurePath™ lines, document batch records, and maintain quality standards.

Qualifications include a high school diploma, detail orientation, and familiarity with computers. Prior packaging operator experience is preferred; associate degree a plus.

Qualifications

• Minimum 12 months as Packaging Operator or 3+ years in FDA-regulated, high-volume manufacturing.
• High school diploma or GED.
• Willing to work flexible schedules including rotating shifts and overtime.
• Able to comprehend and follow written and verbal English instructions.
• Experience troubleshooting/optimizing manufacturing processes.
• Demonstrated mastery of at least two BD-SurePath™ operations and documentation.
• Education/Experience: Associate’s Degree preferred.

Responsibilities

• Operate equipment to generate finished goods for BD-SurePath™, BD-SurePath Plu, and ProEx C as required.
• Ensure finished product is manufactured according to procedures and quality specs; inspect and remove defects.
• Document manufacturing activities accurately, including device history records.
• Monitor production lines, notify supervision of deviations from normal conditions.
• Complete scheduled production runs to meet production schedules or Kanban.
• Support Kaizen/Six Sigma and continuous improvement activities.

Skills

Attention to detail

Computer literacy

Process data analysis

Troubleshooting manufacturing

Education

High school diploma/GED

Associate’s Degree (preferred)

Tools

BD-SurePath™

Job description

Machine Operator

Burlington, NC

1 Year Contract

9:00 PM to7:00 AM

Weekly 40.00 hours[Mon-Thu]

Comments/Special Instructions

• Pay Rate $13/hr.

Qualifications

• Must have performed the Packaging Operator job function for a minimum of 12 months or have 3+ years of experience working in high-volume, FDA-regulated, and automated manufacturing
• High school diploma/GED
• Strong attention to detail
• Must be willing and/or able to work a flexible work schedule including static or rotating shifts and overtime as required
• Familiarity with computers for general business use
• Must be able to comprehend and follow written and verbal instructions in English
• Experience troubleshooting/optimizing manufacturing processes
• Demonstrated mastery of at least two BD-SurePath™ manufacturing operations and the associated documentation, as established through supervisor evaluation/observation or 3+ years of experience operating similar processes in an FDA-regulated environment
• Ability to perform calculations to analyze process data for comparison to targets/metrics
• Ability to chart and interpret process data to detect and react to trends Education and Experience
• Preferred: Associate’s Degree in a field related to manufacturing, biology, or business
  

• Must have performed the Packaging Operator job function for a minimum of 12 months or have 3+ years of experience working in high-volume, FDA-regulated, and automated manufacturing
• High school diploma/GED
• Strong attention to detail
• Must be willing and/or able to work a flexible work schedule including static or rotating shifts and overtime as required
• Familiarity with computers for general business use
• Must be able to comprehend and follow written and verbal instructions in English
• Experience troubleshooting/optimizing manufacturing processes
• Demonstrated mastery of at least two BD-SurePath™ manufacturing operations and the associated documentation, as established through supervisor evaluation/observation or 3+ years of experience operating similar processes in an FDA-regulated environment
• Ability to perform calculations to analyze process data for comparison to targets/metrics
• Ability to chart and interpret process data to detect and react to trends Education and Experience
• Preferred: Associate’s Degree in a field related to manufacturing, biology, or business
  

Responsibilities

• Utilize a variety of equipment and processes to generate finished goods for BD-SurePath™, BD-SurePath Plu, and ProEx™ C as required to satisfy all customer, internal, clinical, and other demand.
• Ensure finished product is manufactured in accordance with procedures and Quality specifications. Inspect in-process parts to ensure consistent quality and remove defective product, packaging, and component material.
• Responsible for ensuring timely and accurate documentation of all manufacturing activities, including but not limited to device history records and inventory counts.
• Perform simple mathematical calculations required to assist in completion of batch record.
• Monitor production lines, anticipating and reacting to problems. Notify supervision of deviations from normal operating conditions.
• Complete scheduled production runs in an efficient, timely manner to meet production schedules or maintain Kanbans.
• Utilize Kaizen Action Sheets on a regular basis to suggest and implement improvements to existing processes.
• Participate in Continuous Improvement projects or events as requested.
• Assist with inventory counting activities as required.
• Participate in safety audits as required and actively engage in daily safety discussions/observations.
• Perform routine cleaning of processing equipment.
• Abide by all personal protective equipment and product contamination control (i.e. gowning) requirements.
• Handle hazardous waste as appropriate.
• Assist with validation activities for new or modified processes and products.
• Assist with routine maintenance activities as necessary - this includes participation in Preventive Maintenance work and manufacturing line recovery
• Ensure all work instructions accurately reflect current processes; notify area lead in any instance where approved work instructions are inconsistent or inaccurate.
• Independently operate (or lead the operation of) all distinct manufacturing lines on a regular basis.
• Participate in Lean/Six Sigma activities on a regular basis to drive continuous improvement of Reagent processes/products.
• Assist with root-cause analysis activities for process, product, or inventory exceptions.
  

Job Dimensions

• Works on assignments that are semi-routine in nature where ability to recognize and assist in recovery from deviation from specification is required.
• Performs routine work with virtually no supervisory input and new assignments with detailed instructions from supervision.
• Interacts daily with other employees within Reagent Manufacturing to ensure robust understanding of current activities across the department.
• Operates independently within the constraints of approved process-related documentation.
• Interacts daily with counterparts in Quality Control to ensure open communication lines to maximize process efficiency and product quality.
• Assists in the development and training of Packaging Operators to build their skill-sets beyond entry-level tasks.
• Trains or seeks training on new and revised procedures to maintain currency on all areas of job scope.