Senior Quality Engineer

Kelly Science, Engineering, Technology & Telecom
Petaluma, CA

Senior Quality Engineer (Validation) | Biotech | $65–$75/hr | Onsite – Petaluma, CA

If you’ve actually owned IQ/OQ/PQ and want to be part of a team bringing a product to market, this is the kind of role that moves your career forward.

We’re supporting a growing biotech company tackling antibiotic-resistant infections. They’re in a critical commercialization phase and need someone who can step in and execute, not just oversee.


What makes this role different

  • You’ll be hands-on with validation, not just reviewing documents
  • Direct involvement in scale-up and commercialization
  • High-visibility work across Engineering, Manufacturing, and Quality
  • Fast-moving environment where your work actually impacts outcomes

What you’ll be doing

  • Leading and executing IQ/OQ/PQ for equipment, processes, and systems
  • Writing and executing validation protocols and reports
  • Supporting deviations, investigations, and CAPAs
  • Partnering cross-functionally to support product development and manufacturing ramp
  • Helping ensure the site is inspection-ready

What they’re looking for

  • 6–10+ years in a GMP-regulated environment (pharma, biotech, or med device)
  • Strong hands-on validation experience (not just exposure)
  • Proven experience authoring and executing IQ/OQ/PQ
  • Comfortable working onsite in Petaluma, CA

Nice to have

  • Combination product or medical device experience
  • CSV exposure
  • Experience supporting scale-up or commercialization

Details

  • 📍 100% onsite – Petaluma, CA
  • 💼 Contract-to-hire (strong intent to convert)
  • 💰 $65–$75/hr depending on experience


If you’re someone who likes to own your work, move fast, and be part of building something, this is worth a conversation.


Apply directly or message me to learn more.

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