Packaging Development Engineer – Secondary & Tertiary Packaging Innovation (Biologics / Combination Products / GMP) (JP15071N)

3 Key Consulting • Thousand Oaks, CA

19h • Onsite

About The Position

This role supports our client’s Manufacturing Science & Technology organization and is responsible for the development, optimization, qualification, and lifecycle management of secondary and tertiary packaging systems for commercial and development-stage products. The engineer will contribute to packaging solutions supporting biologics, sterile injectables, and combination products such as prefilled syringes and autoinjectors. The successful candidate will work cross-functionally with Operations, Quality, Supply Chain, Regulatory, Device Development, and external suppliers to drive packaging innovation, improve manufacturability, ensure regulatory compliance, and support product launches, technology transfers, and supply continuity. Key responsibilities include designing and improving cartons, labels, inserts, and distribution packaging; maintaining component specifications; leading engineering studies; evaluating new materials and packaging technologies; supporting supplier qualification activities; and ensuring packaging systems meet performance, traceability, and global compliance requirements. This position requires a motivated engineer with strong communication skills, sound technical judgment, attention to detail, and the ability to influence stakeholders in a fast-paced manufacturing environment. Candidates with a passion for continuous improvement, innovation, and practical engineering execution will be highly valued.

Requirements

• Bachelor’s degree in Mechanical Engineering, Materials Science, Chemical Engineering, Biomedical Engineering, or related field.
• 2+ years of professional scientific engineering 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 Amgen’s Thousand Oaks campus.

Nice To Haves

• Master’s degree in Engineering or related field.
• 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 (e.g., prefilled syringes, autoinjectors).
• Create novel designs and maintain component specifications for cartons, labels, and distribution packaging.
• Packaging manufacturing process engineering studies
• Ensure compliance with global regulatory expectations
• Prepare and review packaging documentation for regulatory submissions.
• Support technology transfer, scale-up, and readiness activities at Amgen manufacturing sites and contract manufacturing locations.
• 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
• Number of Employees: 1-10 employees