Engineer, Packaging and Labeling

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

  • 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