Engineer, Packaging and Labeling

Orca Bio•Sacramento, CA

3d•Onsite

About The Position

Orca Bio is a commercial-stage biotechnology company focused on redefining the transplant process with next-generation cell 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. 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.

Requirements

Bachelor’s degree in Life Sciences, Engineering, or related field (required)
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
Excellent communication and problem solving skills, with a desire to improve upon established processes

Nice To Haves

Advanced degree (MS, MBA, or PhD) preferred
Experience in biotechnology and cell therapy manufacturing preferred
Experience with commercial packaging, labeling, and cold chain strongly preferred

Responsibilities

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.
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.
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.
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.
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.