Ampcus, Inc. | Packaging Operator DE | christiana, de

6 days ago

Christiana DE United States Ampcus, Inc. Full time

• Owns process and equipment performance by operating packaging equipment (tablet fillers, thermoformers, labelers, case packers, etc.) 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.

• Perform maintenance activities including Center lines and troubleshooting equipment jams. Responsible for visual inspection, cleaning (including quarterly cleanings) and tightening of equipment.

• Responsible to execute and improve changeover, assemble and disassembly, adjust equipment to optimize performance. Provides direction on optimal sequence.

• Responsible for set up and first point of troubleshooting of packaging equipment and to document event forms or perform problem solving activities.

• Alert’s supervision of any irregularities in procedures or equipment operations.

• 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)

• Responsible of documenting and follow electronic batch record.

• 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, GMP, PET and Site meetings.

• Active participation and/or facilitation of line tier meetings to record performance, opportunities and recognize best practices.

• Share knowledge with co-workers for training purposes.

• Work effectively in teams to meet monthly demand requirements.

• Identify areas for continuous improvement and efficiency improvements. Participate in Kaizen and SMED events.

• Participate in deviation investigations and help drive to root cause using tools such as 5- Why. Documentation of event work sheet.

• 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) Accountable for change over performance, MTBS and metrics related to operations (SQSCP) following lean standards.

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

• Must be flexible to change.

• Ability to perform duties with minimum supervision.

• Assist in the (re)qualification and (re)validation of processing equipment by supporting engineering in protocols and testing. As well as participates on factory acceptance test as per required.

• Create and/or modify standard work cards and procedures (SOP).

• Responsible for recycling and waste management of line operations.

• Active participation on PET and site strategy initiatives.

  • Ampcus, Inc. | Packaging Operator DE | christiana, de

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