About The Position

This position involves supporting senior staff in the initiation, design, and delivery of projects, particularly for container closure integrity testing (CCIT) related scope. The role requires employing basic engineering skills and practices to gather user requirements and translate them into technical documentation for execution. The engineer will assist with project definition by performing engineering studies and assessments for CCIT system installations, and perform field evaluations of existing systems, providing engineering design recommendations and supporting the development of CCIT technologies. The position is split between lab and office work. Equipment validation is a highly desired skillset. The role involves working with other associates on testing and conducting testing themselves. Day-to-day responsibilities include supporting the development of technical documentation related to CCI testing, execution of protocols to support development, and writing technical documentation to support findings and results. This is a heavy documentation role.

Requirements

  • Masters Degree OR Bachelor’s degree and 2 years of related medical/biopharma development or Operations experience; OR Associate degree and 6 years of related medical/biopharma development or Operations experience.
  • Biopharma or Biotech experience and/or Equipment Validation experience within another industry.
  • Documentation writing (procedures, technical assessments, engineering drawings, etc).
  • Solid modeling (fixture development).
  • Meetings.
  • Testing.

Nice To Haves

  • Equipment qualification- Equipment validation is a highly desired skillset.

Responsibilities

  • Support senior staff in the initiation, design, and delivery of projects, particularly for container closure integrity testing (CCIT) related scope.
  • Employ basic engineering skills and practices to gather user requirements and translate them into technical documentation for execution.
  • Assist with project definition by performing engineering studies and assessment for CCIT system installations.
  • Perform field evaluations of existing systems and provide engineering design recommendations.
  • Support development of CCIT technologies.
  • Support development of technical documentation related to CCI testing.
  • Execution of protocols to support development.
  • Writing of technical documentation to support findings and results.
  • Testing.

Benefits

  • W2 with benefits
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