Packaging Engineer

Job Title: Packaging Engineer

Supervisor:    Director Process Engineering

The Packaging Engineer is responsible for the design, validation and implementation packaging materials, packaging equipment and systems. The position interfaces with all departments to ensure materials and processes are compatible for technology transfer and consistent with established project plans and corporate goals. All activities are performed according to internal Quality System requirements, cGMP and ISO 13485 standards.

Specific Tactical Responsibilities:

  • Collaborate with packaging material vendors to evaluate and select cost effective packaging materials that meet industry standards for sterile barrier packaging systems (if required)
  • Manage capital projects including design, purchase, validation and implementation of equipment and packaging processes to meet project schedule and budgetary requirements
  • Interact with multiple departments internally and external vendors to coordinate multidisciplinary tasks
  • Identify calibration requirements and tolerances for new equipment and instruments
  • Prepare draft-operating procedures for new equipment and processes and works with Document Control to ensure final processes are implemented through the document mastering process
  • Develop/edit master part specifications and/or artwork specification to meet regulatory and marketing requirements
  • Perform process/product risk assessments and prepare reports according to company procedures
  • Prepare equipment (IOQ, PQ) and process validation (PV) protocols
  • Coordinate activity with the Packaging Department to execute equipment and process validations according to approved protocols
  • Generate discrepancy/deviation and validation summary reports documenting results of validation activities
  • Responsible for other duties and projects as assigned

Required Qualifications:

  • Bachelor’s degree in in Packaging Technology, Mechanical Engineering or related field or related experience
  • Minimum of 5 years’ experience in a cGMP regulated environment
  • Experience with medical device packaging equipment and processes
  • Demonstrated experience with material, equipment, and process validation according to pharmaceutical and medical device industry standards

Desired Experience, Knowledge, and Skills:

  • Master’s Degree in Mechanical or Packaging Engineering
  • Previous experience with sterile barrier packaging systems
  • Experience with a heat sealing, cartoning, and on-line barcode printing and coding
  • Demonstrated project management experience
  • Excellent equipment and process troubleshooting skills
  • Ability to work autonomously, effectively manage time and deliver results on time
  • Excellent presentation skills, both written and in platform presentation format


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