# Senior Engineer, Process Validation - Cell Therapy at Orca Bio

- Company: Orca Bio
- What the company does: Orca Bio is helping to deliver the promise of cell therapy to patients without compromise. Backed by Lightspeed and Felicis.
- Company website: https://orcabio.com/
- Type: Startups
- Level: Senior
- Location: Sacramento, CA
- Work setup: On-site
- Pay: $110K to $145K base salary per year (USD)
- Posted: 2026-08-11
- Apply by: 2026-10-08
- Apply: https://jobs.lever.co/orcabiosystems/865ba798-7425-488e-adad-277343065b74
- Page: https://www.1752.vc/careers/jobs/orca-bio-senior-engineer-process-validation-cell-therapy/

## About the role

Position Summary: Orca Bio is seeking a highly skilled Senior Process Validation Engineer to join our Validation group in Sacramento, CA. In this role, you will hold primary ownership over the Process Validation lifecycle—including overall Process Validation Master Plans (PVMP), Process Performance Qualification (PPQ), Aseptic Process Simulations (APS), and Shipping Validation.

## What they're looking for

- Own the strategy, execution, and documentation for PPQ campaigns
- Author, review, and approve Process Validation Plans, Protocols, and Reports supporting Stage 2 validation activities
- Lead and execute Solution / In-Process Hold Studies and Solution / In-Process Mixing Studies to evaluate process limits and solution stability
- Develop and support PPQ campaigns, including authoring PPQ Protocols and Reports and conducting thorough verification of PPQ pre-requisites prior to execution
- Bachelor’s or Master’s degree in Chemical Engineering, Biomedical Engineering, Biotechnology, Life Sciences, or a related discipline
- Experience:

Tags: Quality Assurance