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Aditi Consulting
EngineerAditi Consulting • Thousand Oaks, CA
Engineer

Engineer

Aditi Consulting • Thousand Oaks, CA
30+ days ago
Job type
  • Full-time
Job description

Payrate: $ - $

Responsibilities:
  • Lead development and optimization of secondary & tertiary packaging for biologics, sterile injectables, and combination products (, 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 self-life studies Cold-chain and environmental conditioning Packaging line engineering studies
  • Ensure compliance with global regulatory expectations (FDA, EMA, ISO ).
  • Prepare and review packaging documentation for regulatory submissions.
  • Support tech transfer, scale-up, and readiness activities at manufacturing sites and CMOs.
  • Lead investigations into 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:
  • Bachelor’s degree in Packaging Engineering, Mechanical Engineering, Materials Science, Chemical Engineering, Biomedical Engineering, or related field.
  • + 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.

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

Must Have Skills:
  • Experience with SBS paperboard
  • Material Science Experience
  • Experience with stack up analysis

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Engineer • Thousand Oaks, CA

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