Engineer, Packaging and Labeling

Engineer, Packaging and Labeling

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 investigational 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.

The Engineer, Packaging and Labeling is responsible for the lifecycle management of Final Drug Product, packaging systems, labeling components, cold chain packaging equipment, and cryopreservation equipment supporting the manufacture and distribution of commercial cell therapy products. This role ensures packaging and labeling systems comply with GMP, regulatory, and patient-specific requirements while maintaining product integrity throughout manufacturing, cryogenic storage, transportation, and delivery.

The position serves as the technical owner for printed packaging components, artwork implementation, packaging specifications, cold chain packaging systems, cryopreservation equipment, and associated manufacturing documentation.

Physical Demands

• 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.

Work Conditions

• 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.

Essential Duties &

Key Responsibilities:

Packaging Engineering

• Serve as technical owner for primary, secondary, and tertiary packaging systems used for commercial cell therapy products.
• Design, develop, qualify, and maintain packaging configurations for cryopreserved drug products.
• Develop packaging solutions that protect product quality throughout manufacturing, storage, shipping, and administration.
• Evaluate new packaging technologies and recommend improvements to increase robustness, efficiency, and cost effectiveness.
• Support lifecycle management of packaging systems from development through commercial manufacturing. Patient-Centric Delivery Execution

Cold Chain Packaging Systems

• Own the technical performance of cold chain shipping systems including: cryogenic dry shippers, refrigerated transport systems, temperature monitoring devices, data loggers, and qualified insulated shipping containers.
• Develop packaging qualification protocols including Operational Qualification (OQ) and Performance Qualification (PQ).
• Support thermal mapping, shipping validation, lane qualification, and transportation studies.
• Analyze shipping performance data and implement corrective actions when necessary.

Cryopreservation Equipment

• Serve as technical owner for cryopreservation equipment including controlled-rate freezers, liquid nitrogen storage systems, cryogenic storage vessels, freezer racks and storage accessories, and temperature monitoring…