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Senior Packaging Engineer, Biopharma, Combination Medical Device; JP
Job in
Thousand Oaks, Ventura County, California, 91362, USA
Listed on 2025-12-01
Listing for:
3key Consulting, Inc.
Full Time
position Listed on 2025-12-01
Job specializations:
-
Engineering
Packaging Engineer, Quality Engineering
Job Description & How to Apply Below
Senior Packaging Engineer, Biopharma, Combination Medical Device (JP14804)
Location: Thousand Oaks, CA 91320
Employment Type: Contract
Business Unit: Manufacturing Science & Technology
Function: Process Development / Engineering / Operations
Duration: 12 months with likely extension or conversion to permanent
Rate: $48-52 on W2 with Benefits
Posting Date: 11/28/2025
Responsibilities- Lead development and optimization of secondary & tertiary 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, and 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 company’s 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.
- 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.
- On-Site
- Packaging Engineering Experience
- Experience with Paper-Based Packaging
Two interviews, possibly three — video conference.
We invite qualified candidates to send your resume to If you decide that you’re not interested in pursuing this position, please feel free to take a look at the other positions on our website. You are welcome to also share this opportunity with anyone you think might be interested in applying for this role.
#J-18808-LjbffrPosition Requirements
10+ Years
work experience
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