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Validation Engineer

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OPULENTSOFT

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Location:
United States , Northridge

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Category:
IT - Software Development

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Contract Type:
Not provided

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Salary:

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Job Description:

The individual chosen for this position will primarily be responsible for closing out process validations of a pilot manufacturing line for next-generation subcutaneous glucose sensors. Day to day responsibilities include execution of validation test plans and generation of validation test reports. In addition, this individual will aid in the setup of a high volume manufacturing line for the same product (characterization, IQ/OQ/PQ).

Job Responsibility:

  • Coordinate sample builds and maintain traceability documentation
  • Prepare process validation protocols (IQ/OQ/PQ) and generate accompanying test plans/reports
  • Route and track all protocol documents for proper approvals
  • Characterize new process equipment
  • Document experiments and results in engineering reports
  • Create and present summary presentations to management
  • Collaborate and coordinate with outside vendors
  • Provide technical support to engineering, and provide line support as required
  • Obtain test data and provide statistical analysis to generate status reports for engineering
  • Initiate revision of controlled drawings of components and assemblies as needed
  • Create or revise assembly procedure documents
  • Provide process expertise and training as necessary
  • Identify safety issues in the immediate work environment and other work areas and recommend solutions for improvement

Requirements:

  • BS in Biomedical/Mechanical/Chemical Engineering
  • Experience in working in a clean room environment or wet lab environment
  • Experience in analysing large data sets and performing relevant statistical analysis
  • Proficient in writing technical reports, procedures, and/or reference documents
  • Ability to multitask and meet deadlines
  • Must have excellent verbal and written communication skills
  • Must have experience in developing Design of Experiments (DOEs)
  • Must have strong attention to detail
  • Proficient in MiniTab statistical analysis software

Nice to have:

  • Medical device or healthcare industry experience
  • Proficient in MiniTab statistical analysis software

Additional Information:

Job Posted:
January 02, 2026

Work Type:
On-site work
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