Packaging Engineer – Cell Therapy, Cold Chain & Labeling

Orca Bio; Sacramento (CA); Sur place; USD 85 000 - 105 000; Plein temps

Avantages offerts par ce poste

Pre-IPO equity

Annual bonus

Medical, dental, and vision benefits

PTO

401(k) plan

Parental leave

On-site lunches

Résumé du poste

Orca Bio in Sacramento, CA is seeking an Engineer, Packaging and Labeling to own lifecycle management of Final Drug Product packaging, labeling components, and cold chain equipment for commercial cell therapy products. You will ensure GMP compliance and maintain product integrity from manufacturing through distribution.

You will lead printing and artwork processes, qualify packaging systems, and partner with Regulatory and Quality to implement changes.

Qualifications

• Minimum: Bachelor’s degree in Life Sciences, Engineering, or related field.
• Advanced degree (MS, MBA, or PhD) preferred.
• 2+ years of experience in biopharmaceutical manufacturing, with a focus on packaging operations, cold chain management, or cell/gene therapy.
• Knowledge of cGMP regulations and regulatory expectations.
• Background in lean manufacturing and operational excellence methodologies.

Responsabilités

• Own the primary, secondary, and tertiary packaging systems for commercial cell therapy products.
• Develop and maintain packaging configurations for cryopreserved drug products.
• Ensure packaging and labeling compliance with GMP and regulatory requirements.
• Lead packaging qualification and lifecycle management from development to commercial manufacturing.
• Support cold chain packaging systems and cryogenic equipment qualification and maintenance.
• Collaborate with Regulatory Affairs and Quality on labeling updates and changes.

Connaissances

Communication

Problem solving

Formation

Bachelor’s degree in Life Sciences, Engineering, or related field

MS, MBA, or PhD preferred

Description du poste

Orca Bio in Sacramento, CA is seeking an Engineer, Packaging and Labeling to own lifecycle management of Final Drug Product packaging, labeling components, and cold chain equipment for commercial cell therapy products. You will ensure GMP compliance and maintain product integrity from manufacturing through distribution.

You will lead printing and artwork processes, qualify packaging systems, and partner with Regulatory and Quality to implement changes.