Packaging Operator 4 - Weekend Shift

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This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.

Your Role:

The Packaging Operator 4 will be a subject matter expert of several areas in the department and will be responsible for assembling, operating, and monitoring state of the art packaging fill lines. They will be responsible for training lower-level operators on equipment and operations of which they are considered subject matter experts. The Packaging Operator IV will be expected to complete appropriate packaging documentation per FDA, ISO, and GMP procedures and deliver products into inventory.

• Shift: Weekend Shift: Friday, Saturday, and Sunday from 7:00AM to 7:30PM.
• Direct packaging operators in the set-up and operation of the automated filling lines.
• Install format change parts and adjust machine settings to complete changeover.
• Conduct line clearance and review format change parts and settings to verify line readiness.
• Set up pumps, filters, sensors, and level control system to ensure continuous product supply to the fill line.
• Utilize touch screen human machine interface (HMI) to operate filling line and adjust filling parameters.
• Set-up and operate automated labeler, labeler inspection camera, and tamper banding equipment.
• Coordinate packaging operator activities to maximize total line effectiveness of the filling operation.
• Anticipate and resolve bottlenecks and malfunction issues that inhibit process flow.
• Troubleshoot issues with the fill line.
• Escalate line malfunctions, maintenance and repair issues to minimize downtime.
• Disassemble and clean all parts upon completion of line run.
• Lead shift change discussions to completely and accurately communicate line status, problems, and issues to incoming shift.
• Maintain format change parts and supplies in an organized fashion.
• Train packaging operators on key entry points of line operations such as bottle unscrambling, intermediate tank connections and set-ups used for pack-off stations.
• Assist with the evaluation of new filling equipment.
• Contribute packaging expertise to review of new packaging business opportunities.
• Setup, operate and clean lyophilizers.
• Manually fill liquids or powders.
• Utilize semi-automated equipment to fill liquids or powders.
• Troubleshoot problems with equipment and processes.
• Fill products utilizing aseptic techniques.
• Perform fill in environmentally controlled areas.
• Fill hazardous products.
• Utilize pumps to transfer bulk solutions.
• Use electronic balances to properly weigh materials.
• Filter bulk material using pumps and in-line filters or vacuum filters.
• Follow all quality and safety procedures. Support quality systems.
• Always follow safety procedures.
• Document all equipment used and verify calibration status.
• When applicable, utilize computerized data collection system to generate fill line report for batch record.
• Ensure timely and accurate documentation of all line operations.
• Oversee compilation of batch records and all ancillary documentation.
• Don, doff, use, and clean PPE.
• Be familiar with hazards common to assigned work and take action to correct unsafe situations.
• Participate in required safety activities such as training sessions, meetings, and safety inspections.
• Develop and assist in the implementation of process improvement ideas.
• Comply with the requirements of ISO 13485 and ISO 9001.
• Participate in 6S activities.
• Maintain good housekeeping and audit readiness.
• Assist in performing instrument qualifications, operation qualifications, and validations.
• Assist in writing and updating equipment specific OPs.
• Coordinate and direct packaging operators in operation of fill line.
• Responsible for training lower-level operators on equipment and operations of which they are considered subject matter experts.
• Provide trainee feed-back and performance information to Packaging Management.