Cleanroom Kit Assembly Technician

Job Description

As a Cleanroom Kit Assembly Technician, you are the hands behind the product. Working inside our ISO Class 7 cleanroom, you’ll build custom diagnostic and medical device kits to client-approved work instructions – placing, labeling, and packaging components in the exact sequence and configuration each program requires.

This is detail work performed at volume. You’ll verify component lot numbers against the batch record before a single item goes into a kit, maintain the documentation that makes each unit traceable back to its source materials, and gown and de-gown according to cleanroom protocol at every entry. Every kit you build passes through 100% final inspection, and you’ll be expected to catch issues long before they get there.

You’ll work alongside quality, inventory, and program teams on projects that range from a few hundred units to full production runs supporting at-home testing programs nationwide. Training is provided on our quality system, cleanroom discipline, and the specific builds you’re assigned – what we’re looking for is the temperament to do repetitive, exacting work without letting your standards slip on unit four hundred.

Job Requirements

This role suits someone who takes pride in consistency and can stay focused through detailed, repetitive tasks. Prior cleanroom or regulated manufacturing experience is a strong plus, but we will train candidates who bring the right attention to detail and work ethic. You should be comfortable following written procedures precisely and speaking up the moment something looks wrong.

Required qualifications:

  • High school diploma or GED
  • Ability to follow detailed written work instructions and batch records without deviation
  • Strong manual dexterity and hand-eye coordination for small-component handling
  • Ability to stand for extended periods and lift up to 30 lbs
  • Legible handwriting and accurate documentation habits
  • Reliable attendance and the flexibility to support occasional overtime during peak production

Preferred qualifications:

  • Experience working in an ISO Class 7 (or cleaner) cleanroom environment
  • Familiarity with ISO 13485, cGMP, or FDA-regulated manufacturing
  • Prior experience in medical device, diagnostics, or pharmaceutical assembly
  • Basic computer literacy for scanning, inventory, and production tracking systems
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