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Validation Engineer

Nanomix is the leader in the development of mobile, affordable point-of-care diagnostics, offering a handheld testing platform, the Nanomix eLab, and assays that provide rapid, accurate, quantitative information for use in settings where time-to-diagnosis is critical for clinical decision-making and improved patient care. Our goal is to expand access to quality healthcare by bringing diagnostics to the point of initial patient interaction, whether in the hospital or in pre-hospital, remote, or alternative settings.

This position is for an experienced engineer who will be responsible for management and execution of qualification activities for manufacturing equipment and facilities. You will play a key role in the growth of the company’s manufacturing capacity. You will lead multiple concurrent equipment commissioning activities, including developing SOPs, maintenance & calibration, authoring & performing validation protocols (IQ/OQ/PQ) and preparing reports.

Primary Responsibilities and Duties

  • Write and perform equipment commissioning, qualification & validation protocols for manufacturing equipment and facilities
  • Resolve validation exceptions, protocol discrepancies
  • Develop equipment maintenance & calibration procedures
  • Deploy new equipment onto manufacturing line
  • Author staff training materials, including equipment SOPs
  • Interact with new equipment vendors

Minimum Requirements

  • B.S. (or higher) in science or engineering discipline
  • 2+ years of experience working in equipment and/or process validation
  • Exceptional communication skills
  • Experience working in a multi-disciplinary team
  • Data driven, results focused
  • Proficient in Microsoft Word, Excel

Additional Desirable Skills

  • Biotech / life sciences laboratory experience
  • Understanding of FDA, GMP, GDP, and ISO guidelines for manufacturing of medical devices
  • Prior experience in manufacturing of FDA-regulated medical devices
  • Experienced in ISO13485 medical device development
  • New product introduction (NPI) exposure

 

For other inquiries about employment opportunities at Nanōmix, please send your resume or CV to:

Nanōmix, Inc. is an equal opportunity employer.

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