Job Details

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 supportinga 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.