GMP) - (JP15071)

3 Key Consulting•Thousand Oaks, CA

8d•Onsite

About The Position

This role is responsible for leading the development, optimization, and validation of secondary and tertiary packaging systems for biologics, sterile injectables, and combination products (e.g., prefilled syringes and autoinjectors). The engineer will support the full packaging lifecycle, including component specification, material selection, and execution of packaging studies such as transportation simulation (ISTA/ASTM), aging, shelf-life, and cold-chain conditioning. The position requires strong knowledge of cGMP and global regulatory requirements (FDA, EMA, ISO), along with experience preparing packaging documentation for regulatory submissions. The engineer will partner cross-functionally to support tech transfer, scale-up, and manufacturing readiness activities across internal sites and CMOs. Responsibilities also include leading investigations into packaging deviations, driving CAPA and continuous improvement initiatives, and collaborating with suppliers to qualify components and manage change control. This is a highly collaborative role requiring strong technical expertise in packaging engineering, material science, and distribution systems, with the ability to operate effectively in a regulated biopharmaceutical environment.

Requirements

Bachelor’s degree in Packaging Engineering, Mechanical Engineering, Materials Science, Chemical Engineering, Biomedical Engineering, or related field.
7+ years of packaging engineering experience in biopharmaceutical, pharmaceutical, or medical device environments.
Strong understanding of cGMP, sterile product packaging, and biologics/combination product considerations.
Experience with packaging validation and ISTA/ASTM distribution testing.
Excellent communication skills and ability to collaborate across functions.
Ability to work onsite at Amgen’s Thousand Oaks campus.
Experience with SBS paperboard
Material Science Experience
Experience with stack up analysis

Nice To Haves

Master’s degree in Engineering or related field.
Experience with combination products, injection devices, and cold-chain distribution systems.
Knowledge of paperboard, structural design & FEA
3-4+ years of experience

Responsibilities

Package Development
Lead development and optimization of secondary & tertiary packaging packaging for biologics, sterile injectables, and combination products (e.g., prefilled syringes, autoinjectors).
Create and maintain component specifications for vials, stoppers, syringes, seals, 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 line engineering studies
Ensure compliance with global regulatory expectations (FDA, EMA, ISO 11607, USP).
Prepare and review packaging documentation for regulatory submissions.
Support tech transfer, scale-up, and readiness activities at Amgen manufacturing sites and CMOs.
Lead investigations for packaging deviations, component failures, and operational issues; drive CAPA and continuous improvement.
Partner with suppliers and Procurement to qualify components, assess supplier capability, and manage change notifications.
Represent Packaging Engineering on cross-functional project teams, ensuring alignment with design control and DHF requirements.