Equipment Maintenance Technician

Job Title:       Equipment Maintenance Technician

Supervisor:    Packaging Supervisor

Strategic Focus Areas:

  • Participant in projects and activities which support the advancement of syringe assembly operations
  • Subject matter expert for the equipment, process flow, documentation and training of activities within the scope of traying/pouching, labeling and sterilization.
  • Leader in cost reduction, efficiency and value stream planning

Specific Tactical Responsibilities:

  • Perform the mechanical set-up and breakdown of automated equipment involving moving parts and software programs
  • Manage electronic files requiring the loading and deletion of files required for variable printing of regulated information, including product artwork, in packaging operations.
  • Perform equipment trouble shooting activities addressing unexpected equipment performance
  • Execute VHP sterilization cycles, including review of sterilization records for accuracy
  • Optimize throughput by adjusting equipment settings within validated set points to gain process efficiencies
  • Revise cGMP documentation to optimize work flow and to clarify work instructions
  • Maintain current training on all assigned procedures to include read & understood, skills development and classroom training activities as required
  • Perform training activities with Packaging Operators to develop the required skill and to ensure job specific activities are conducted according to approved procedures
  • Provide daily instructions to Packaging Operators on packaging and sterilization operations to ensure daily output is meeting the master schedule
  • Provide recommendations regarding the enhancement of equipment to advance syringe assembly operations
  • Provide recommendations regarding employee performance, including annual reviews, promotions and action required to meet expectations
  • Other duties and projects as assigned

Job Complexity:

The position requires responsibility for operation of automated equipment and electronic files where adherence to proper safety and cGMP procedure is required in order to perform work activities.  The Equipment Maintenance Technician usually receives little instruction on routine work and detailed instructions and training on complex assignments.

Required Qualifications:

  • Trade school diploma, technical certification or degree
  • 4+ years of high throughput automated equipment experience in the medical device/pharmaceutical industry requiring the maintenance of electronic files
  • 2+ years of experience training, coaching and providing direction to Operators or direct reports
  • 2+ years working with sterilization equipment, preferably VHP technology
  • Ability to work flexible hours to complete work activities

Desired Experience, Knowledge, and Skills:

  • Previous experience as a group or team leader
  • Experience working in a cleanroom wearing gowning apparel
  • Demonstrated computer skills including the ability to create and maintain spreadsheets
  • Previous experience maintaining ERP/MRP systems

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