Packaging Development Engineer – Secondary & Tertiary Packaging Innovation; ISTA/Validation
Job in
Thousand Oaks, Ventura County, California, 91362, USA
Listed on 2026-04-29
Listing for:
3key Consulting, Inc.
Full Time
position Listed on 2026-04-29
Job specializations:
-
Engineering
Packaging Engineer, Manufacturing Engineer, Quality Engineering
Job Description & How to Apply Below
Overview
Job Title:
Packaging Development Engineer – Secondary & Tertiary Packaging Innovation (ISTA / Validation / GMP) - JP15071
Location:
Thousand Oaks, CA 91320
Employment Type:
Contract
Business Unit:
Manufacturing Science & Technology
Duration: 1+ year (with likely extensions and/or conversion to permanent)
Responsibilities- Lead development and optimization of secondary & tertiary packaging for biologics, sterile injectables, and combination products.
- Create novel designs and maintain component specifications for 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
- Packaging manufacturing process engineering studies
- Ensure compliance with global regulatory expectations (FDA, EMA, ISO, USP).
- Prepare and review packaging documentation for regulatory submissions.
- Support technology transfer, scale-up, and readiness activities at client manufacturing sites and contract manufacturing locations.
- Lead investigations for packaging deviations, component failures, and operational issues; drive CAPA and continuous improvement.
- Partner with suppliers and Supply Chain to qualify components, assess supplier capability, manage change notifications and implement new material technologies.
- Represent Packaging Engineering on cross-functional project teams, ensuring alignment with design control and traceability requirements.
- Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience.
- Excellent communication skills and ability to collaborate and influence across functions.
- Attention to detail with a mindset of getting things done correctly and robustly the first time.
- 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.
- Experience with structural design, FEA and utilization of artificial intelligence.
- Experience with GMP, GDP, GD&T principles.
Up to 3 interviews: 1st round with manager; 2nd & 3rd rounds will be panel interviews with team members.
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