Packaging Operator

2nd Shift: 3:50 PM – 2:20 AM (Monday – Thursday)

Overview:

Follow established procedures and guidelines to form a variety of simple, manual tasks that form part of a production process. Load materials into production machines. Remove, pack, and sort raw materials or finished products. Collect, and dispose of garbage and production waste according to the organization's waste removal and recycling policies. Clean production equipment and work areas.

·         Must demonstrate ability to properly operate equipment, perform equipment set-up/change-over/clean-ups, assist in preventative maintenance and troubleshoot equipment problems in a safe and efficient manner.

·         Must understand and comply with cGMP’s, SOPs and site safety procedures. As well to follow good housekeeping rules.

·         Verify correctness of product and components for the NDC packaged.

·         Supply equipment with components and product. Lifting requirements may be up to 30 lbs.

·         Perform detection system challenges on applicable equipment.

·         Utilizing standard work, responsible for execution and improvement of changeover of packaging assets including, assembly / disassembly, and centerline adjustment to optimize equipment performance.

·         Clean and purge packaging equipment.

·         Accountable for accurately documenting packaging and cleaning activities in Packaging worksheets, Equipment Cleaning Logbooks, and within performance tracking systems (Traksys)

·         Perform quality attribute inspections and in-process testing (torques, induction seal integrity, leak tests, appearance, etc.)

·         Rework packages according to SOPs or Rework Packaging Order to correct deviations.

·         Attend regular SHE and GMP meetings

·         Work effectively in teams to meet monthly demand requirements.

·         Identify areas for continuous improvement and efficiency improvements.

·         Participate in deviation investigations and help drive to root cause using tools such as 5- Why.

·         Accountable for Line performance (OEE) and able to report hourly status of line to affected personnel to ensure timely resolution to issues. (i.e. Facilitators, Engineers)

·         Must be able to work other shifts, weekends, alternative schedules when production demands require.

Qualifications:

·         High School Diploma/GED

·         Basic mechanical aptitude

·         Experience in a production environment is preferred

·         Knowledge of pharmaceutical production (i.e. cGMPs) is preferre