Senior Engineer, Process Validation - Cell Therapy

More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a commercial-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.

We have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.

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.

You will work closely with Manufacturing (MFG), MSAT, CMC, Quality Assurance, and Supply Chain to establish, verify, and maintain the validated state across our cell therapy drug product processing and shipping channels.