Packaging Development Engineer – Secondary & Tertiary Packaging Innovation (ISTA / Validation / GMP) - (JP15071)

3 Key Consulting • Thousand Oaks, CA

6d • Onsite

About The Position

This role is responsible for leading the development, optimization, and validation of secondary and tertiary packaging systems supporting biologics, sterile injectables, and combination products. The engineer will support packaging innovation, material selection, manufacturing readiness, and packaging performance across commercial and development programs. The position requires strong collaboration and communication skills with the ability to influence cross-functional teams including Quality, Operations, Supply Chain, Manufacturing, Regulatory, and external suppliers. The engineer will support packaging studies including transportation simulation, aging, shelf-life, environmental conditioning, packaging process studies, and supplier qualification activities. This is a highly visible role requiring a motivated engineer who brings strong problem-solving ability, continuous improvement mindset, technical curiosity, and a passion for driving robust packaging solutions.

Requirements

• Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience.
• Excellent communication skills and ability to collaborate and influence across functions.
• Attention to detail with a mindset of getting things done correctly and robustly the first time.
• Ability to work onsite at client’s Thousand Oaks campus.

Nice To Haves

• Master’s degree in Engineering or related field.
• Experience with combination products, injection devices, and cold-chain distribution systems.
• Experience with structural design, FEA and utilization of artificial intelligence.
• Experience with GMP, GDP, GD&T principles.

Responsibilities

• Lead development and optimization of secondary & tertiary packaging for biologics, sterile injectables, and combination products.
• Create novel designs and maintain component specifications for cartons, labels, and distribution packaging.
• Develop and execute packaging test protocols including: Transportation simulation (ISTA/ASTM), Aging and shelf-life studies, Cold-chain and environmental conditioning, Packaging manufacturing process engineering studies.
• Ensure compliance with global regulatory expectations (FDA, EMA, ISO, USP).
• Prepare and review packaging documentation for regulatory submissions.
• Support technology transfer, scale-up, and readiness activities at client manufacturing sites and contract manufacturing locations.
• Lead investigations for packaging deviations, component failures, and operational issues; drive CAPA and continuous improvement.
• Partner with suppliers and Supply Chain to qualify components, assess supplier capability, manage change notifications and implement new material technologies.
• Represent Packaging Engineering on cross-functional project teams, ensuring alignment with design control and traceability requirements.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED