Machine Operator

Millenniumsoft•Burlington, NC

74d•Onsite

About The Position

The Machine Operator will 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. This role ensures finished product is manufactured in accordance with procedures and Quality specifications. The operator will inspect in-process parts to ensure consistent quality and remove defective product, packaging, and component material. Responsibilities include timely and accurate documentation of all manufacturing activities, performing simple mathematical calculations, monitoring production lines, and notifying supervision of deviations. The operator will complete scheduled production runs efficiently, utilize Kaizen Action Sheets for process improvements, and participate in Continuous Improvement projects. Additional duties include assisting with inventory counting, safety audits, routine cleaning of processing equipment, handling hazardous waste, assisting with validation activities, and performing routine maintenance. The operator will also ensure work instructions accurately reflect current processes and independently operate distinct manufacturing lines. Participation in Lean/Six Sigma activities and root-cause analysis for exceptions is also expected.

Requirements

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

Nice To Haves

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.