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.