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 the application of basic engineering skills and practices to gather user requirements and translate them into technical documentation for execution. The candidate will assist with project definition by performing engineering studies and assessments for CCIT system installations, perform field evaluations of existing systems, and provide engineering design recommendations. Support for the development of CCIT technologies is also a key aspect of this role. Equipment validation is a highly desired skillset, and the candidate will be involved in testing and conducting tests themselves. The position is split between lab and office work, requiring at least two days a week onsite in Thousand Oaks, CA, with flexibility for full-time onsite work if needed. This role is a supplement to address additional workload on the team.

Requirements

  • Master degree OR Bachelor degree and 2 years of experience
  • Biopharmaceutical or Biotech experience and/or Equipment Validation experience within another industry.
  • Solid modeling (SolidWorks - preferred)
  • Technical Writing
  • Working in a team

Nice To Haves

  • Equipment validation experience

Responsibilities

  • Support senior staff in the initiation, design, and delivery of projects, particularly for container closure integrity testing (CCIT) related scope.
  • Gather user requirements and translate them into technical documentation for execution.
  • Perform engineering studies and assessments for CCIT system installations.
  • Perform field evaluations of existing systems and provide engineering design recommendations.
  • Support development of CCIT technologies.
  • Assist with testing and conduct testing.
  • Support development of technical documentation related to CCI testing.
  • Execute protocols to support development.
  • Write technical documentation to support findings and results.
  • Documentation writing (procedures, technical assessments, engineering drawings, etc).
  • Solid modeling (fixture development).
  • Attend meetings.
  • Perform testing.
  • Perform device disassembly.
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