Engineer, Packaging and Labeling

Orcabiosystems; Sacramento (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

Orcabiosystems seeks an experienced Packaging Engineer to own packaging systems for cell therapy products, from design to lifecycle management.

You will develop configurations for cryopreserved drugs and oversee cold chain packaging, including qualification protocols and data‑driven improvements.

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or related field is required.
• Advanced degree preferred (MS, MBA, or PhD).
• 2+ years in biopharmaceutical manufacturing with a preference for cell/gene therapy, packaging operations and/or cold chain.
• Knowledge of cGMP regulations and regulatory expectations.
• Lean manufacturing and operational excellence experience.
• Experience with commercial packaging, labeling, and cold chain preferred.
• Excellent communication and problem-solving skills.

Responsibilities

• Own primary, secondary, and tertiary packaging systems for cell therapy products.
• Design, develop, qualify, and maintain packaging configurations for cryopreserved products.
• Develop packaging solutions to protect product quality through manufacturing, storage, shipping, and administration.
• Evaluate new packaging technologies and drive improvements in robustness, efficiency, and cost.
• Support lifecycle management of packaging systems from development to commercial manufacturing.
• Own cold chain packaging systems including cryogenic dry shippers and data loggers.
• Develop packaging qualification protocols (OQ/PQ) and support validation activities.
• Analyze shipping performance data and implement corrective actions.
• Manage lifecycle of printed packaging components and ensure GMP compliance.
• Support artwork management and regulatory labeling updates.

Skills

2+ years biopharmaceutical experience

Regulatory understanding

Lean manufacturing

Communication

Problem solving

Cell/gene therapy exposure

Education

Bachelor’s degree in Life Sciences/Engineering

Advanced degree (MS/MBA/PhD) preferred

Job description

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.

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.

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
• 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

Benefits

• Pre-IPO equity and annual bonus
• Competitive medical, dental, and vision benefits
• Paid time off (PTO)
• 401(k) plan
• Life and accidental death and disability coverage
• Parental leave benefits
• Subsidized daily lunches and snacks at on-site locations

We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.