3 Key Consulting, Inc. · 1 month ago
Senior Packaging Engineer, Biopharma, Combination Medical Device (JP14804)
Thousand Oaks, CA
Full-time
Onsite
Senior Level
$48/hr - $52/hr3 Key Consulting is hiring a Senior Packaging Engineer for a consulting engagement with a leading global biopharmaceutical company. The role involves leading the development and optimization of packaging for biologics and combination products, ensuring compliance with regulatory expectations, and collaborating with cross-functional teams.
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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:
Transportation simulation (ISTA/ASTM)
Aging and shelf-life studies
Cold-chain and environmental conditioning
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
Qualification
Required
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, 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
Preferred
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
Benefits
Benefits
Company
3 Key Consulting, Inc.
3Key Consulting specializes in the rapid recruitment and placement of business and IT professional within the life sciences and healthcare industries.
Founded in 2009
51-200 employees
H1B Sponsorship
3 Key Consulting, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2020 (6)
Funding
Current Stage
Growth StageLeadership Team
Ahmad Hussein
CEO, Executive Talent Acquisition, Business Development Leader
Recent News
2025-09-29
Company data provided by crunchbase