Engineer, Packaging and Labeling

Job description

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. 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 & Work Conditions - Production Associates: 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. - Must meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for up to 3 consecutive hours at a time, minimal movement in the cleanroom, and working with or around human blood, blood-derived materials, cells, other biological materials, and alcohol-based sprays. 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. - Must be comfortable regularly participating in video-based meetings. ### 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 - 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 - Temperature monitoring systems - Support equipment qualification, preventive maintenance strategies, and lifecycle management. - Partner with Engineering and Validation to commission and qualify new cryogenic equipment. - Investigate equipment-related deviations and implement engineering improvements. **Labeling and Packaging Components** - Manage the technical lifecycle of printed packaging components including: - - Patient-specific labels - Product labels - Cartons - Instructions for Use (IFUs) - Package inserts - Shipping labels - Cryogenic labels - Ancillary labeling components - Own component specifications and ensure compliance with GMP and regulatory requirements. - Develop and maintain packaging component drawings and technical specifications. - Support supplier qualification and ongoing supplier technical oversight. **Artwork Management** - Serve as engineering representative for artwork implementation. - Review artwork changes for manufacturability and packaging compatibility. - Support change control activities associated with labeling and printed packaging. - Verify artwork aligns with packaging specifications and manufacturing processes. - Collaborate with Regulatory Affairs and Quality to implement approved labeling updates. ### Minimum Qualifications: - Bachelor’s degree in Life Sciences, Engineering, or related field (required) - Advanced degree (MS, MBA, or PhD) preferred - 2+ years of experience in biopharmaceutical manufacturing, with a strong preference for cell or gene therapy, packaging operations and / or cold chain management - Knowledge of cGMP regulations and regulatory expectations - Background in lean manufacturing and operational excellence methodologies ### Preferred Qualifications: - Experience in biotechnology and cell therapy manufacturing preferred - Experience with commercial packaging, labeling, and cold chain strongly preferred - Excellent communication and problem solving skills, with a desire to improve upon established processes