Engineer

• depending on experience Responsibilities
• 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: o Transportation simulation (ISTA/ASTM) o Aging and shelf-life studies o Cold-chain and environmental conditioning o 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 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. ________________________________________ Basic Qualifications
• Bachelors 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

• Excellent communication skills and ability to collaborate across functions.
• Ability to work onsite at Thousand Oaks campus. ________________________________________ Preferred Qualifications
• Masters degree in Engineering or related field.
• Experience with combination products, injection devices, and cold-chain distribution systems.
• Knowledge of paperboard, structural design & FEA