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Senior Packaging Engineer
Job in
Thousand Oaks, Ventura County, California, 91362, USA
Listed on 2025-12-07
Listing for:
ACL Digital
Seasonal/Temporary
position Listed on 2025-12-07
Job specializations:
-
Engineering
Quality Engineering, Packaging Engineer
Job Description & How to Apply Below
Senior Packaging Engineer
Location:
Thousand Oaks, CA 91320
Type of Work:
Only on W2 basis
Senior Packaging Engineer role with one of our pharmaceutical client in Thousand Oaks, CA.
Responsibilities- Lead development and optimization of secondary & tertiary packaging for biologics, sterile injectables, and combination products such as 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.
- 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 client 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.
- 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 Client’s Thousand Oaks campus.
- 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.
Contact:
Satya S, Sr. Operations Manager
Phone #:
Email:
Seniority level:
Mid‑Senior level
Employment type:
Contract
Job function:
Manufacturing
Industries:
Pharmaceutical Manufacturing and Biotechnology Research
Position Requirements
10+ Years
work experience
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