Job Description

Target PR Range: 38-48/hr
*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.
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Basic Qualifications
• 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 Thousand Oaks campus.
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Preferred Qualifications
• 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

Job Tags

Contract work,

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