Senior Engineer, Process Validation - Cell Therapy

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.

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.

• Production Associate Roles : Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.
• Most roles must be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.
• Many roles must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs, as well as regularly participate in video-based meetings. Also, may be required to work scheduled overtime, weekends, or holidays based on business needs.

• Own the strategy, execution, and documentation for PPQ campaigns.
• Author, review, and approve Process Validation Plans, Protocols, and Reports supporting Stage 2 validation activities.